Humoral testing unit

ABSTRACT

A blood testing unit is provided with a closed vessel having an outer vessel body and an inner vessel body, and a reagent layer is accommodated in the closed vessel. Reagents which react with a blood sample are supported on the reagent layer. The closed vessel is comprised such that at least either one of the outer vessel body and the inner vessel body is provided with an aperture, through which air is capable of being introduced from the exterior to the interior of the one vessel body, and the one vessel body is provided with a sealing member for closing the aperture.

This nonprovisional application claims priority under 35 U.S.C. § 119(a)on Patent Application No(s). 2002-092227 filed in JAPAN on Mar. 28,2002, which is(are) herein incorporated by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to a humoral testing unit for use in performing atest of bodily fluids of humans and other animals.

2. Description of the Related Art

As blood testing units for use in performing tests of blood of humansand other animals, blood testing units comprising a slide-shaped supportand a reagent layer carried on the slide-shaped support, which reagentlayer is capable of undergoing a reaction with blood plasma or bloodserum and forming a predetermined color, have heretofore been proposed.The blood testing units are proposed in, for example, U.S. Pat. No.5,051,901.

In cases where the blood testing units described above are utilized,blood plasma or blood serum is spotted onto the reagent layer of theblood testing unit. Thereafter, light is irradiated to the reagent layerhaving formed a color, and an intensity of light reflected from thereagent layer is measured. In this manner, a concentration of a specificsubstance contained in the blood plasma or the blood serum, or the like,is capable of being quantitatively analyzed in accordance with theintensity of the reflected light. An example of an analysis apparatusfor performing the blood tests in the manner described above is alsodisclosed in U.S. Pat. No. 5,051,901.

In cases where the aforesaid blood testing units comprising theslide-shaped support and the reagent layer carried on the slide-shapedsupport are utilized, the blood plasma or the blood serum is exposed onthe blood testing unit to the exterior all the time during the bloodtest. Therefore, there is the risk that persons in charge of the bloodtests will come in contact with the blood plasma or the blood serum bymistake and will catch an infectious disease, such as HIV.

Accordingly, in order to eliminate the problems described above, a bloodtesting unit comprising a transparent tubular vessel and a reagent fixedwithin the tubular vessel has been proposed in, for example, JapaneseUnexamined Patent Publication No. 2000-74910. In cases where theproposed blood testing unit is utilized, whole blood is introduced intothe tubular vessel and is subjected to a centrifugal separation process.Also, the blood plasma or the blood serum, which has been separated fromsolid constituents, is brought into contact with the reagent having beenfixed within the tubular vessel, and results of the reaction with thereagent, such as color formation, are inspected visually or withmeasurement of intensity of reflected light. Therefore, with theproposed blood testing unit, after the whole blood has been introducedinto the tubular vessel, the blood test is capable of being performedsuch that the person in charge of the blood test may not come in contactwith blood constituents.

Also, there may be reagents being used for the blood test, which requiresupply of oxygen, such that the reagents are capable of undergoingreactions with substances to be detected, or such that the reagents arecapable of completing the reactions with substances to be detectedwithin a predetermined reaction time. However, in cases where thereagents are enclosed in a closed vessel described above, problems suchthat the reagents are not capable of reacting with the blood sample, orthe time necessary for the reaction to be completed becomes extremelylong may occur.

Problems basically similar to the problems described above may occur incases of the blood testing unit for performing tests on bodily fluidsother than the blood of animals such as urine, sweat, or cerebrospinalfluid.

SUMMARY OF THE INVENTION

The object of the present invention is to provide a humoral testingunit, which is capable of avoiding problems from occurring in that testof bodily fluids is not capable of being performed or test of bodilyfluids requires long time because oxygen is not supplied to reagentswhich are accommodated in a closed vessel.

The present invention provides a humoral testing unit, comprising:

-   -   a closed vessel provided with a aperture, which is formed at a        certain area of the closed vessel, through which air is capable        of being introduced from the exterior to the interior of the        closed vessel, which closed vessel is provided with a sealing        member for closing the aperture; and    -   a reagent being used to perform a humoral test, which is located        in the closed vessel.

The humoral testing unit in accordance with the present invention shouldpreferably be modified such that the sealing member is a sheet-shapedmember, which is adhered to the closed vessel. Alternatively, thehumoral testing unit in accordance with the present invention shouldpreferably be modified such that the sealing member is a plug-shapedmember, which is fitted into and close the aperture, or the like.

The humoral testing unit in accordance with the present invention shouldpreferably be modified such that the closed vessel comprises an outervessel body, which has a bottom wall, and an inner vessel body, whichhas a bottom wall, and the outer vessel body and the inner vessel bodyare combined with each other, such that the outer vessel body and theinner vessel body are capable of sliding with respect to each other,while a space defined by the outer vessel body and the inner vessel bodyis being kept in an approximately hermetically sealed state, the outervessel body and the inner vessel body thus defining an enclosed space atthe interior in a manner such that a pressure in the enclosed space iscapable of being reduced.

In cases where the closed vessel is constituted of the outer vessel bodyand the inner vessel body described above, the humoral testing unit inaccordance with the present invention should preferably be modified suchthat the outer vessel body and the inner vessel body are provided withlocking means for keeping the states of the outer vessel body and theinner vessel body when at least either one of the outer vessel body andthe inner vessel body has been moved with respect to the other in adirection which increases a volume of the enclosed space defined at theinterior by the outer vessel body and the inner vessel body, and thepressure in the enclosed space has thus been set at a negative pressure.

Also, in cases where the closed vessel is constituted of the outervessel body and the inner vessel body described above, the humoraltesting unit in accordance with the present invention should preferablybe modified such that an O-ring is fitted onto an outer peripheral wallof the inner vessel body, the O-ring being capable of keeping the space,which is defined by the outer vessel body and the inner vessel body, inan approximately hermetically sealed state, and the outer vessel bodyand the inner vessel body are capable of sliding with respect to eachother, while the O-ring fitted onto the outer peripheral wall of theinner vessel body is being in contact with an inner peripheral wall ofthe outer vessel body.

Further, in cases where the closed vessel is constituted of the outervessel body and the inner vessel body described above, the humoraltesting unit in accordance with the present invention should preferablybe modified such that an outer peripheral wall of the inner vessel bodyis provided with an engagement section, which projects outwardly fromouter peripheral wall of the inner vessel body, an inner peripheral wallof the outer vessel body is provided with an engagement section, whichprojects inwardly from the inner peripheral wall of the outer vesselbody, and the engagement section of the inner vessel body and theengagement section of the outer vessel body are capable of engaging witheach other in order to prevent the inner vessel body and the outervessel body from separating from each other.

The humoral testing unit in accordance with the present invention isprovided with the aperture, through which air is capable of beingintroduced from the exterior to the interior of the one vessel body, andthe one vessel body is provided with the sealing member for closing theaperture. In cases where oxygen is necessary for the reaction of thereagent with the bodily fluid, the sealing member may be removed fromthe aperture in order to introduce air into the vessel, and oxygen isthus capable of being supplied to the reagent. Accordingly, with thehumoral testing unit in accordance with the present invention, problems,such as the test not being able to be performed or the test taking longtime, are capable of being prevented.

In cases where the aperture is closed with the sealing member after airhas been introduced into the vessel, there is no risk that the person incharge of the bodily fluid test will come in contact with the bodilyfluid constituents within the vessel.

Also, the humoral testing unit in accordance with the present inventionmay be modified such that the closed vessel comprises the outer vesselbody, which has the bottom wall, and the inner vessel body, which hasthe bottom wall, and the outer vessel body and the inner vessel body arecombined with each other, such that the outer vessel body and the innervessel body are capable of sliding with respect to each other, while thespace defined by the outer vessel body and the inner vessel body isbeing kept in the approximately hermetically sealed state, the outervessel body and the inner vessel body thus defining the enclosed spaceat the interior in the manner such that the pressure in the enclosedspace is capable of being reduced. In such cases, at least either one ofthe outer vessel body and the inner vessel body is capable of beingmoved with respect to the other in the direction heading away from eachother, and the pressure in the enclosed space is thus capable of beingset at a negative pressure. In cases where the pressure in the enclosedis thus set at the negative pressure, and the blood sampling needle, orthe like, is then stuck in the humoral testing unit, the bodily fluidsample is capable of being sucked strongly into the enclosed space ofthe closed vessel. Alternatively, the bodily fluid sampling needle, orthe like, maybe stuck in the humoral testing unit, and the pressure inthe enclosed space may then be set at the negative pressure. Also, inthis case, the bodily fluid sample is capable of being sucked stronglyinto the enclosed space of the closed vessel. As a result, apredetermined amount of the bodily fluid sample is capable of beingsampled quickly into the closed vessel, and the efficiency with whichthe humoral test is performed is capable of being enhanced.

Also, in cases where the closed vessel is constituted of the outervessel body and the inner vessel body described above, the humoraltesting unit in accordance with the present invention may be modifiedsuch that the outer vessel body and the inner vessel body are providedwith the locking means for keeping the states of the outer vessel bodyand the inner vessel body when at least either one of the outer vesselbody and the inner vessel body has been moved with respect to the otherin the direction which increases the volume of the enclosed spacedefined at the interior by the outer vessel body and the inner vesselbody, and the pressure in the enclosed space has thus been set at thenegative pressure. With the modification described above, problems, suchas the outer vessel body and the inner vessel body naturally returningto the original states, i.e. the pressure in the enclosed spacereturning from the negative pressure to the atmospheric pressure, arecapable of being prevented. Therefore, the outer vessel body and theinner vessel body need not be held with the tips of the fingers of theperson in charge of the humoral test such that the two vessel bodies donot return to the original states. Accordingly, the operation forintroducing the bodily fluid sample into the closed vessel is capable ofbeing performed easily.

Further, in cases where the closed vessel is constituted of the outervessel body and the inner vessel body described above, the humoraltesting unit in accordance with the present invention may be modifiedsuch that the O-ring is fitted onto the outer peripheral wall of theinner vessel body, the O-ring being capable of keeping the space, whichis defined by the outer vessel body and the inner vessel body, in theapproximately hermetically sealed state, and the outer vessel body andthe inner vessel body are capable of sliding with respect to each other,while the O-ring fitted onto the outer peripheral wall of the innervessel body is being in contact with the inner peripheral wall of theouter vessel body. With the modification described above, in cases whereat least either one of the outer vessel body and the inner vessel bodyis moved with respect to the other, in the direction heading away fromeach other, and the pressure in the enclosed space is thus set at thenegative pressure, the state of the negative pressure is capable ofbeing set more reliably. Also, since the O-ring described above isprovided, problems, such as the bodily fluid constituents leakingthrough a gap between the outer vessel body and the inner vessel body tothe exterior of the closed vessel, are capable of being prevented.

Further, in cases where the closed vessel is constituted of the outervessel body and the inner vessel body described above, the humoraltesting unit in accordance with the present invention may be modifiedsuch that the outer peripheral wall of the inner vessel body is providedwith the engagement section, which projects outwardly from outerperipheral wall of the inner vessel body, the inner peripheral wall ofthe outer vessel body is provided with the engagement section, whichprojects inwardly from the inner peripheral wall of the outer vesselbody, and the engagement section of the inner vessel body and theengagement section of the outer vessel body are capable of engaging witheach other in order to prevent the inner vessel body and the outervessel body from separating from each other. With the modificationdescribed above, problems, such as the outer vessel body and the innervessel body separating by accident from each other, and the bodily fluidconstituents leaking from the outer vessel body and the inner vesselbody to the exterior, are capable of being prevented.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded perspective view showing a first embodiment of thehumoral testing unit in accordance with the present invention,

FIG. 2 is a partially cutaway side view showing the humoral testing unitof FIG. 1,

FIG. 3 is a plan view showing a reagent layer of the humoral testingunit of FIG. 1,

FIG. 4 is a partially cutaway side view showing the humoral testing unitof FIG. 1 in a state in which a blood sample is introduced into thehumoral testing unit,

FIG. 5 is a perspective view showing a first blood testing apparatusthat employs the humoral testing unit of the present invention,

FIG. 6 is a partially cutaway side view showing the humoral testing unitof FIG. 5,

FIG. 7 is a partially cutaway side view showing a second embodiment ofthe humoral testing unit in accordance with the present invention,

FIG. 8 is a partially cutaway side view showing a third embodiment ofthe humoral testing unit in accordance with the present invention and asecond humoral testing apparatus,

FIG. 9 is a partially cutaway side view showing a third humoral testingapparatus,

FIG. 10 is a partially cutaway side view showing a fourth humoraltesting apparatus,

FIG. 11 is a perspective view showing a fourth embodiment of the humoraltesting unit in accordance with the present invention,

FIG. 12 is a perspective view showing a major part of a fifth humoraltesting apparatus,

FIG. 13 is a perspective view showing a major part of a sixth humoraltesting apparatus,

FIG. 14 is a perspective view showing a fifth embodiment of the humoraltesting unit in accordance with the present invention,

FIG. 15 is a plan view showing a different example of the reagent layerconstituting the humoral testing unit in accordance with the presentinvention,

FIG. 16 is a perspective view showing a further different example of thereagent layer constituting the humoral testing unit in accordance withthe present invention,

FIG. 17 is a perspective view showing a sixth embodiment of the humoraltesting unit in accordance with the present invention,

FIG. 18 is a front view showing a major part of a seventh humoraltesting apparatus,

FIG. 19 is a perspective view showing examples of dummy units, which maybe utilized in the humoral testing apparatus,

FIG. 20 is a perspective view showing a different example of a dummyunit, which may be utilized in the humoral testing apparatus,

FIG. 21 is a perspective view showing a major part of an eighth humoraltesting apparatus, and

FIG. 22 is a perspective view showing a major part of a ninth embodimentof the humoral testing apparatus.

DESCRIPTION OF THE PREFFERED EMBODIMENTS

The present invention will hereinbelow be described in further detailwith reference to the accompanying drawings.

FIG. 1 is an exploded perspective view showing a blood testing unit 10,which is a first embodiment of the humoral testing unit in accordancewith the present invention. FIG. 2 is a partially cutaway side viewshowing the blood testing unit 10 of FIG. 1. As illustrated in FIG. 1and FIG. 2, the blood testing unit 10 comprises a circularcylinder-shaped outer vessel body 11, whose lower end portion in FIG. 1and FIG. 2 is open, and a circular cylinder-shaped inner vessel body 21,which has a bottom wall 23 at lower end portion in FIG. 1 and FIG. 2. Byway of example, each of the outer vessel body 11 and the inner vesselbody 21 is made from a transparent synthetic resin. The outer vesselbody 11 has a size of, for example, an outer diameter of 15 mm×a heightof 30 mm. The inner vessel body 21 has a size of, for example, an outerdiameter of 10 mm×a height 30 mm. Alternatively, each of the outervessel body 11 and the inner vessel body 21 may be made from glass, orthe like.

The outer vessel body 11 has an upper wall 14 at an end portion on theupper side in FIG. 1 and FIG. 2. The upper wall 14 is provided with acircular opening 13. Ordinarily, the opening 13 is closed by a rubberfilm 15, which is adhered to an inner surface of the upper wall 14. Aswill be described later, the rubber film 15 constitutes the bloodintroducing section. Also, a circular blood constituent separatingmembrane 16 is formed with an insert molding process and held within theouter vessel body 11. The blood constituent separating membrane 16 isconstituted of a porous structure material. The porous structurematerial acts such that, when a blood sample is supplied to the porousstructure material, the porous structure material allows the bloodplasma and/or blood serum to pass therethrough and obstructs solidconstituents from passing therethrough. In this embodiment, by way ofexample, a polysulfone membrane having a pore diameter falling withinthe range of 0.5 μm to 50 μm is utilized as the porous structurematerial. Further, an annular engagement section 17 is formed on aninner peripheral wall of the outer vessel body 11. The annularengagement section 17 projects inwardly from the inner peripheral wallof the outer vessel body 11 and at a position close to an open end ofthe outer vessel body 11, which open end is formed at the lower end ofthe outer vessel body 11 in FIG. 1 and FIG. 2.

The lower end of the inner vessel body 21 in FIG. 1 and FIG. 2 is closedby the bottom wall 23. An upper end of the inner vessel body 21 is open,and a reagent layer 24 is fitted to the upper end of the inner vesselbody 21. Also, an O-ring 25 is fitted onto an outer peripheral wall ofthe inner vessel body 21 and at a position comparatively close to theupper end of the inner vessel body 21. Further, an air introducingaperture 26, which communicates the interior of the inner vessel body 21and the exterior of the inner vessel body 21 to each other, is formedthrough the peripheral wall of the inner vessel body 21. The airintroducing aperture 26 is closed by a sealing member 27, which isadhered to the outer peripheral wall surface of the inner vessel body21.

By way of example, the reagent layer 24 comprises a nitrocelluloseporous membrane having a pore diameter of 0.45 μm (supplied by MilliporeCorporation), two glucose detecting spots, which are of the pigmenttypes and have absorption characteristics such that the maximumabsorption wavelength is in the vicinity of 505 nm, and two uric aciddetecting spots, which are of the pigment types and have absorptioncharacteristics such that the maximum absorption wavelength is in thevicinity of 650 nm, the four detecting spots being formed on thenitrocellulose porous membrane. The reagent layer 24 may be prepared inthe manner described below. Specifically, for example, an MES buffersolution, which contains glucose oxidase, peroxidase, 1,7-dihydroxynaphthalene, and 4-amino antipyrine and has been adjusted to a pH valuefalling within the range of 5.5 to 6.5, is spotted to two positions onthe nitrocellulose porous membrane. Also, a buffer solution, whichcontains uricase, peroxidase, and a diallyl imidazole type ofleuco-pigment, is spotted to two positions on the nitrocellulose porousmembrane. The thus formed four spots are then dried, and the reagentlayer 24 is thus obtained. Since the support of the reagent layer 24 isformed from the nitrocellulose porous membrane described above, when theblood plasma and/or the blood serum is supplied to the reagent layer 24,the blood plasma and/or blood serum spreads in the spread direction ofthe reagent layer 24.

FIG. 3 is a plane view showing the reagent layer 24 described above. InFIG. 3, reference numerals 24 a, 24 a denote the two glucose detectingspots, and reference numerals 24 b, 24 b denote the two uric aciddetecting spots. In this embodiment, the reagent layer 24 is alsoprovided with a bar code 24 c acting as a mark, which representsinformation concerning the blood testing unit 10, i.e. a productionserial number of the blood testing unit 10, a kind of the blood testingunit 10, or the like. The bar code 24 c will be described in detaillater.

As illustrated in FIG. 2, the outer vessel body 11 and the inner vesselbody 21 are combined with each other in order to constitute the bloodtesting unit 10. When the inner vessel body 21 is accommodated withinthe outer vessel body 11, the O-ring 25 of the inner vessel body 21 andthe annular engagement section 17 of the outer vessel body 11 interfereslightly with each other. However, in cases where the inner vessel body21 is pushed slightly forcibly into the outer vessel body 11, theperipheral wall of the outer vessel body 11 and the O-ring 25 of theinner vessel body 21 undergo elastic deformation, and the O-ring 25 isthus capable of passing over the annular engagement section 17.

In the state shown in FIG. 2, the inner vessel body 21 is capable ofmoving in the major axis direction, i.e. vertically in FIG. 2, withinthe outer vessel body 11. At this time, the inner vessel body 21 slideson the inner peripheral wall of the outer vessel body 11 with the O-ring25 intervening therebetween. Therefore, an enclosed space defined by theinner vessel body 21 and the outer vessel body 11 is formed.Specifically, in this embodiment, the outer vessel body 11 and the innervessel body 21 co-operate to constitute a closed vessel, such that theinterior of the closed vessel is kept in a water-tight state withrespect to the exterior.

Also, particularly, the enclosed space described above is kept in anapproximately hermetically sealed state with respect to the exterior bythe O-ring 25. Therefore, when the inner vessel body 21 is pulleddownwardly, i.e. in the direction heading away from the upper wall 14 ofthe outer vessel body 11, from the state shown in FIG. 2, the pressurewithin the enclosed space is reduced to a negative pressure. When theinner vessel body 21 is thus pulled and moved downwardly by apredetermined distance, the O-ring 25 of the inner vessel body 21 andthe annular engagement section 17 of the outer vessel body 11 come intoengagement with each other. Therefore, the inner vessel body 21 isprevented from separating from the outer vessel body 11.

How a blood test is performed by use of the blood testing unit 10described above will be described hereinbelow. Firstly, how an operationfor taking a blood sample is performed will be described hereinbelow. Inorder for the blood sample to be taken, the inner vessel body 21 ispulled in the direction heading away from the upper wall 14 of the outervessel body 11 in the manner described above, and the pressure withinthe enclosed space, which is defined by the inner vessel body 21 and theouter vessel body 11, is thus set at a negative pressure. The thus setstate is illustrated in FIG. 4. Thereafter, as illustrated in FIG. 4,one tip of a blood sampling needle 30, whose other tip has been stuckin, for example, the upper arm of a human body, is stuck through therubber film 15 of the outer vessel body 11 into the enclosed spacedescribed above. As a result, since the pressure within the enclosedspace has been set at the negative pressure, whole blood 31 passesthrough the blood sampling needle 30 and is thus introduced into theenclosed space. As illustrated in FIG. 4, the whole blood 31 spreadsover the blood constituent separating membrane 16. Solid constituents ofthe whole blood 31 are caught on the surface of the blood constituentseparating membrane 16, and the blood plasma and/or the blood serumpasses through the blood constituent separating membrane 16.

There is a correlation between the number of the amount of the wholeblood 31, which is taken into the blood testing unit 10 in the mannerdescribed above, and the distance by which the inner vessel body 21 ispulled downwardly from the state shown in FIG. 2. The correlation hasbeen confirmed with blood sampling experiments, which were conductedunder conditions having been set to be uniform with the cases where thewhole blood 31 is taken by use of the blood testing unit 10 in themanner described above. Specifically, for example, in cases where thedistance by which the inner vessel body 21 is pulled downwardly is setat 1 cm, 2 cm, and 4 cm, the amount of the whole blood 31 taken into theblood testing unit 10 is capable of being set at 10 μl (microliter), 20μl, and 40 μl, respectively.

In this embodiment, as described above, the pressure within the enclosedspace defined by the inner vessel body 21 and the outer vessel body 11is set at the negative pressure, and thereafter the blood samplingneedle 30 is stuck through the rubber film 15. Alternatively, after theblood sampling needle 30 has been stuck through the rubber film 15, theinner vessel body 21 may be pulled downwardly, and the pressure withinthe enclosed space may thus be set at the negative pressure.

After the whole blood 31 has been supplied into the blood testing unit10 in the manner described above, the blood sampling needle 30 is pulledout from the rubber film 15. At this time, the hole made by the bloodsampling needle 30 remains in the rubber film 15. However, since therubber film 15 has a high elasticity, in so far as the hole is left asit is, the hole is kept in the closed state by the high elasticity ofthe rubber film 15, and therefore the problems do not occur in that thewhole blood 31 leaks through the hole to the exterior of the bloodtesting unit 10. Also, when the blood sampling needle 30 is being stuckthrough the rubber film 15, the boundary between the outer peripheralwall of the blood sampling needle 30 and the rubber film 15 is kept inan approximately sealed state by the high elasticity of the rubber film15. Therefore, the region within the blood testing unit 10 is kept inthe negative pressure state until the whole blood 31 has been introducedinto the blood testing unit 10. When the whole blood 31 has beenintroduced into the blood testing unit 10, the pressure within the bloodtesting unit 10 returns to the atmospheric pressure.

How a photometric operation is performed will be described hereinbelow.FIG. 5 is a perspective view showing a blood testing apparatus 40, whichis a first blood testing apparatus that employs the humoral testing unitof the present invention. FIG. 6 is a partially cutaway side viewshowing the blood testing unit 40 of FIG. 5. As illustrated in FIG. 5and FIG. 6, the blood testing apparatus 40 comprises a unit receivingsection 42 constituted of a circular cylinder-shaped hole for receivingthe blood testing unit 10, which hole is open at a casing top surface41. The blood testing unit 10 is accommodated in the unit receivingsection 42 with the inner vessel body 21 facing down. Thereafter, theouter vessel body 11 is slightly pushed down and moved with respect tothe inner vessel body 21. As a result, the blood constituent separatingmembrane 16 of the outer vessel body 11 comes into contact with thereagent layer 24 of the inner vessel body 21. This state is illustratedin FIG. 6. Since the reagent layer 24 has been formed in parallel withthe blood constituent separating membrane 16, the entire area of thereagent layer 24 and the entire area of the blood constituent separatingmembrane 16 come into contact with each other.

As described above, solid constituents 31 a of the whole blood 31 arecaught on the upper side of the blood constituent separating membrane16, and the blood plasma and/or the blood serum passes through the bloodconstituent separating membrane 16. Therefore, when the reagent layer 24of the inner vessel body 21 comes into contact with the bloodconstituent separating membrane 16 in the manner described above, theblood plasma and/or the blood serum spreads over the reagent layer 24.Each of the buffer solutions (i.e., the reagents) of the glucosedetecting spots 24 a, 24 a and the uric acid detecting spots 24 b, 24 b,which have been formed on the reagent layer 24, undergoes a reactionwith the blood plasma and/or the blood serum and forms a color as aresult of the reaction.

As illustrated in detail in FIG. 6, the blood testing apparatus 40comprises a light source unit 44 for producing measuring light 43. Theblood testing apparatus 40 also comprises a light guide member 45 forguiding the measuring light 43 having been produced by the light sourceunit 44. The light guide member 45 may be constituted of, for example,an optical fiber. The blood testing apparatus 40 further comprises afilter unit 46, which is located at an intermediate point of the lightguide member 45 and selects the wavelength of the measuring light 43.The blood testing apparatus 40 still further comprises a light intensitymeasuring section 47, which is located within the light guide member 45at a position in the vicinity of a light radiating end portion of thelight guide member 45.

The light source unit 44 comprises a light emitting diode, whichproduces light having wavelengths in the vicinity of 505 nm, and a lightemitting diode, which produces light having wavelengths in the vicinityof 650 nm. Either one of the two light emitting diodes is actuatedselectively. The filter unit 46 comprises a filter, which transmits onlylight having a wavelength of 505 nm, and a filter, which transmits onlylight having a wavelength of 650 nm. Either one of the two filters isselectively inserted into an optical path within the light guide member45. In lieu of the two light emitting diodes described above beingutilized, a white light emitting diode for producing white light, whichcontains light having wavelengths in the vicinity of 505 nm and lighthaving wavelengths in the vicinity of 650 nm, may be utilized.

The filter selecting operation of the filter unit 46 and the lightemitting diode selecting and actuating operation are controlled by acommon control section 53 in a manner interlocked with each other.Specifically, in cases where the light emitting diode for producing thelight having the wavelengths in the vicinity of 505 nm is actuated, thefilter, which transmits only the light having the wavelength of 505 nm,is inserted into the optical path. Also, in cases where the lightemitting diode for producing the light having the wavelengths in thevicinity of 650 nm is actuated, the filter, which transmits only thelight having the wavelength of 650 nm, is inserted into the opticalpath.

The light guide member 45 is located such that the light radiating endportion of the light guide member 45 faces the inner vessel body 21 ofthe blood testing unit 10, which has been accommodated in the unitreceiving section 42 of the blood testing apparatus 40.

The light intensity measuring section 47 comprises an objective lens 48for operating such that, when the measuring light 43 is irradiated tothe reagent layer 24 of the inner vessel body 21 and is reflected asreflected light 43R from the reagent layer 24, the objective lens 48collects the reflected light 43R. The light intensity measuring section47 also comprises an image forming lens 49 for forming an image of thereflected light 43R, which has been collected by the objective lens 48.The light intensity measuring section 47 further comprises atwo-dimensional photodetector 50 located at the position at which theimage of the reflected light 43R is formed. The two-dimensionalphotodetector 50 may be constituted of a CCD image sensor, or the like.

How the blood testing apparatus 40 having the constitution describedabove operates will be described hereinbelow. When the blood testingunit 10 has been accommodated in the unit receiving section 42, thelight source unit 44 and the filter unit 46 are controlled by thecontrol section 53 in the manner described above, and the measuringlight 43 having the wavelength of 505 nm and the measuring light 43having the wavelength of 650 nm are irradiated alternately at intervalsof, for example, 0.1 second through the light guide member 45 to thereagent layer 24 of the inner vessel body 21. In FIG. 6, of themeasuring light 43 radiated out in a divergent light state from thelight radiating end portion of the light guide member 45, only the lightcomponents traveling toward the areas of the reagent layer 24, at whichareas the glucose detecting spots 24 a, 24 a and the uric acid detectingspots 24 b, 24 b have been formed, are illustrated. The intensity of thereflected light 43R having been reflected from the reagent layer 24 isdetected by the two-dimensional photodetector 50.

Each of the buffer solutions (i.e., the reagent) of the glucosedetecting spots 24 a, 24 a and the uric acid detecting spots 24 b, 24 b,which have been formed on the reagent layer 24, has formed the color asa result of the reaction with the blood plasma and/or the blood serum tobe tested. The optical density of each of the glucose detecting spots 24a, 24 a and the uric acid detecting spots 24 b, 24 b is measured atintervals of 0.1 second. Specifically, the two-dimensional photodetector50 has been divided into pixels and is capable of detecting theintensity of the reflected light 43R with respect to each of fine pointson the reagent layer 24. Therefore, the optical density of each of theglucose detecting spots 24 a, 24 a and the uric acid detecting spots 24b, 24 b, whose optical density changes with the passage of time, iscapable of being measured in accordance with a photo detection signal Sobtained from the two-dimensional photodetector 50.

In order for the optical density of each of the glucose detecting spots24 a, 24 a and the uric acid detecting spots 24 b, 24 b to be measuredin accordance with the photo detection signal S obtained from thetwo-dimensional photodetector 50, it is necessary that a correspondencerelationship between the positions on a photo detecting surface of thetwo-dimensional photodetector 50 and the positions on the reagent layer24 is specified. For such purposes, the inner vessel body 21 may beaccommodated always in a predetermined orientation in the unit receivingsection 42. Specifically, for example, a position matching mark may beattached to one position on the outer peripheral wall of the innervessel body 21, and a position matching mark may be attached to oneposition on the inner peripheral wall of the unit receiving section 42.Then, the blood testing unit 10 may be accommodated in the unitreceiving section 42 such that the positions of the two positionmatching marks coincide with each other.

The photo detection signal S, which represents the intensity of thereflected light 43R with respect to each of the glucose detecting spots24 a, 24 a and the uric acid detecting spots 24 b, 24 b, is fed into asignal processing section 51. In accordance with the intensity of thereflected light 43R, the signal processing section 51 calculates theoptical density of each of the glucose detecting spots 24 a, 24 a andthe uric acid detecting spots 24 b, 24 b. Also, the signal processingsection 51 previously stores information representing calibrationcurves, which have been formed in accordance with results of experimentsand represent relationship between concentration of glucose and uricacid and the optical densities of the glucose detecting spots 24 a, 24 aand the uric acid detecting spots 24 b, 24 b. In accordance with thecalibration curves, the signal processing section 51 calculates theconcentrations of glucose and uric acid from the optical densities ofthe detecting spots, whose optical densities change with the passage oftime. Further, the signal processing section 51 feeds a signal Sd, whichrepresents the concentrations of glucose and uric acid having thus beencalculated, into a displaying section 52. In the displaying section 52,the concentrations of glucose and uric acid represented by the signal Sdare displayed as the test results. The conversion of the intensity ofthe reflected light 43R into the optical density is made by utilizingoptical calculation techniques, such as a Lambert-Beer's law and adiffuse reflection formula.

Certain kinds of reagents constituting the detecting spots of thereagent layer 24 require supply of oxygen, such that the reagents arecapable of undergoing reactions with substances to be detected, or suchthat the reagents are capable of completing the reactions withsubstances to be detected within a predetermined reaction time. In caseswhere such kinds of reagents are utilized, after the whole blood 31 hasbeen introduced into the blood testing unit 10 in the manner describedabove, the sealing member 27 having been adhered to the outer peripheralwall surface of the inner vessel body 21 is removed from the outerperipheral wall surface of the inner vessel body 21. As a result, theair introducing aperture 26 having been closed by the sealing member 27is opened, and oxygen contained in air is supplied through the airintroducing aperture 26 to the region within the inner vessel body 21,i.e. to the reagent layer 24. In cases where the air introducingaperture 26 is again closed by the sealing member 27 after air has beenintroduced into the inner vessel body 21, problems, such as the personin charge of the blood test coming in contact with the bloodconstituents within the blood testing unit 10, are capable of beingprevented.

In lieu of the sheet-shaped sealing member 27 described above beingutilized, a plug-shaped sealing member for closing the air introducingaperture 26 may be utilized. In such cases, after air has beenintroduced into the inner vessel body 21, the air introducing aperture26 may again be closed by the plug-shaped sealing member. In thismanner, problems, such as the person in charge of the blood test cominginto contact with the blood constituents within the blood testing unit10, are capable of being prevented.

Ordinarily, in cases where the blood test is performed, the bloodtesting unit 10 is kept at a predetermined temperature by use of anincubator (not shown), and the blood plasma and/or blood serum is causedto react with the reagent at a predetermined temperature higher thanroom temperature, e.g. at a temperature of 37° C. In such cases, asubstance capable of generating heat in the presence of water shouldpreferably be added to the aforesaid nitrocellulose porous membrane,which constitutes the reagent layer 24 and allows the blood plasmaand/or the blood serum to spread. In such cases, when the blood plasmaand/or the blood serum containing water spreads through the reagentlayer 24, the reagent layer 24 is heated with heat generated by theaforesaid substance. In cases where the reagent layer is capable ofbeing heated preliminarily with heat generated by the aforesaidsubstance in the manner described above, the time required for the bloodtesting unit 10 to reach the predetermined temperature in the incubatoris capable of being kept short, and therefore the blood test is capableof being performed with a high efficiency.

As the substance capable of generating heat in the presence of water, analumino-silicate, such as zeolite, slacked lime, a mixture of ironpowder and an oxidizing agent, or the like, may be employed.

In the first blood testing apparatus, the light guide member 45 islocated such that the light radiating end portion of the light guidemember 45 is in contact with a lower surface 42 a of a bottom plate ofthe unit receiving section 42. Therefore, the distance between theobjective lens 48 of the light intensity measuring section 47 and thereagent layer 24, the distance between the image forming lens 49 of thelight intensity measuring section 47 and the reagent layer 24, and thedistance between the two-dimensional photodetector 50 of the lightintensity measuring section 47 and the reagent layer 24 are kept atpredetermined values.

In the first blood testing apparatus, the concentrations of the specificconstituents of the blood plasma and/or the blood serum are calculatedin accordance with the calibration curves in the manner described.Alternatively, instead of the concentrations of the specificconstituents of the blood plasma and/or the blood serum beingcalculated, the signal processing section 51 may perform only theprocessing for calculating the optical density of each of the glucosedetecting spots 24 a, 24 a and the uric acid detecting spots 24 b, 24 bof the reagent layer 24, and the calculated optical densities may bedisplayed in the displaying section 52. As another alternative, thesignal processing section 51 may output a signal, which represents thecalculated optical densities, to the exterior.

As described above, the blood testing unit 10, which is the firstembodiment of the blood testing unit in accordance with the presentinvention, comprises the closed vessel, which is constituted of theouter vessel body 11 and the inner vessel body 21, the blood constituentseparating membrane 16, and the reagent layer 24, which are locatedwithin the closed vessel. Therefore, with the blood testing unit 10, theblood test is capable of being performed by introducing the whole blood31 into the closed vessel, irradiating the measuring light 43 from theexterior of the closed vessel to the reagent layer 24, which has formedthe color as a result of the reaction, and measuring the intensity ofthe reflected light 43R having been reflected from the reagent layer 24,the measurement being made from the exterior of the closed vessel.Specifically, the blood test is capable of being performed such that,after the blood sample has been introduced into the closed vessel, theperson in charge of the blood test may not come in contact with theblood constituents, which are present within the closed vessel.Accordingly, with the blood testing unit 10, problems, such as theperson in charge of the blood test coming in contact with the bloodsample and catching an infectious disease, are capable of beingprevented.

As described above, the blood testing unit 10 is constituted such thatthere is substantially no risk of persons coming in contact with theblood sample from the exterior of the blood testing unit 10. Therefore,after the blood testing unit 10 has been used for the blood test, theblood testing unit 10 may be processed with, for example, an autoclave,and may then be disposed. Accordingly, the blood testing unit 10 iscapable of being utilized as a disposable blood testing unit.

Whether the blood testing unit 10 has already been used or has not yetbeen used for the blood test is capable of being confirmed byinvestigating whether each of the glucose detecting spots 24 a, 24 a andthe uric acid detecting spots 24 b, 24 b of the reagent layer 24 hasformed or has not formed the predetermined color, or whether a mark dueto the blood sampling needle 30 is or is not left on the rubber film 15.Alternatively, such that it is capable of being confirmed moreaccurately whether the blood testing unit 10 has already been used orhas not yet been used for the blood test, the reagent capable ofundergoing the reaction with the blood sample and forming the color as aresult of the reaction may be utilized such that letters, such as“used,” may appear on the reagent layer 24 as a result of the reaction.

Also, with the blood testing unit 10, the blood plasma and/or the bloodserum is separated from the whole blood 31 by the blood constituentseparating membrane 16, which is located within the closed vessel.Therefore, with the blood testing unit 10, particular operations forsetting the blood testing unit 10 on a centrifugal separator in order toseparate the blood plasma and/or the blood serum from the whole blood31, which require considerable time and labor, need not be performed,and the blood test is capable of being performed with a simpleoperation.

Particularly, with the blood testing unit 10, as described above, atleast either one of the outer vessel body 11 and the inner vessel body21 may be moved with respect to the other in the direction heading awayfrom each other, and the pressure in the enclosed space is thus capableof being set at the negative pressure. In cases where the pressure inthe enclosed space within the blood testing unit 10 is thus set atnegative pressure, and the blood sampling needle 30 is then stuckthrough the rubber film 15, the whole blood 31 is capable of beingsucked strongly into the enclosed space of the closed vessel.Alternatively, the blood sampling needle 30 may be stuck through therubber film 15, and the pressure in the enclosed space may then be setat the negative pressure. Also, in this case, the blood sample iscapable of being sucked strongly into the enclosed space of the closedvessel. As a result, a predetermined amount of the whole blood 31 iscapable of being sampled quickly into the closed vessel, and theefficiency with which the blood test is performed is capable of beingenhanced.

Further, with the blood testing unit 10, the blood constituentseparating membrane 16 is constituted of the porous structure material,which allows the blood plasma and/or the blood serum to passtherethrough and obstructs the solid constituents from passingtherethrough. Therefore, the structure for the separation of the bloodplasma and/or the blood serum from the whole blood 31 is capable ofbeing kept simple. Accordingly, the blood testing unit 10 isadvantageous for keeping the size of the blood testing unit small.Furthermore, particularly, the polysulfone membrane, which has the porediameter falling within the range described above, is utilized as theporous structure material. In such cases, the effects of separating theblood plasma and/or the blood serum from the whole blood 31 are capableof being obtained more reliably, and the reliability of the blood testis capable of being enhanced.

Also, with the blood testing unit 10, the blood constituent separatingmembrane 16 is formed with the insert molding process and is thuscombined with the outer vessel body 11 into an integral body. Therefore,the blood constituent separating membrane 16 is secured tightly to theinner peripheral surface of the outer vessel body 11 without any gapbeing formed between the blood constituent separating membrane 16 andthe inner peripheral surface of the outer vessel body 11 over the entireperimeter of the blood constituent separating membrane 16. In suchcases, problems, such as the whole blood 31, from which the blood plasmaand/or the blood serum has not yet been separated, leaking through a gapbetween the blood constituent separating membrane 16 and the innerperipheral surface of the outer vessel body 11 toward the reagent layer24, are capable of being prevented. Accordingly, problems, such as thewhole blood 31 adhering to the reagent layer 24 and obstructing theblood test, or an inaccurate blood test being made due to the wholeblood 31 adhering to the reagent layer 24, are capable of beingprevented.

Further, with the blood testing unit 10, the rubber film 15 constitutingthe blood introducing section is formed at the upper wall 14 of theouter vessel body 11. In such cases, for example, the blood testing unit10 may be held in a state in which the rubber film 15 is located on theside remote from the person in charge of the blood test, and the innervessel body 21 may be pulled toward the person in charge of the bloodtest. With the holding and pulling operation described above, thepressure in the enclosed space of the blood testing unit 10 is capableof being set at the negative pressure. The holding and pulling operationdescribed above is markedly easy to perform, and therefore theintroduction of the blood sample into the blood testing unit 10 iscapable of being performed easily and reliably with the holding andpulling operation described above.

Furthermore, with the blood testing unit 10, the bottom wall 23 of theinner vessel body 21 is formed at the end portion of the inner vesselbody 21, which end portion is remote from the upper wall 14 of the outervessel body 11. Therefore, the distance between the upper wall 14 of theouter vessel body 11 and the bottom wall 23 of the inner vessel body 21is capable of being set to be comparatively long, and the volume of theenclosed space defined by the outer vessel body 11 and the inner vesselbody 21 is capable of being set to be comparatively large. Accordingly,in cases where it is assumed that the volume of the enclosed space is tobe set at a predetermined value, the entire size of the outer vesselbody 11 and the inner vessel body 21 is capable of being set to becomparatively small. As a result, the size of the blood testing unit iscapable of being set to be small.

Also, with the blood testing unit 10, the blood constituent separatingmembrane 16 is secured to the outer vessel body 11, in which the rubberfilm 15 acting as the blood introducing section is secured to the upperwall 14, such that the blood constituent separating membrane 16 facesthe upper wall 14 of the outer vessel body 11. Therefore, the wholeblood 31 having been introduced through the rubber film 15 is capable ofbeing supplied immediately to the blood constituent separating membrane16.

Further, with the blood testing unit 10, the outer vessel body 11 andthe inner vessel body 21 are capable of sliding with respect to eachother, while the O-ring 25 fitted onto the outer peripheral wall of theinner vessel body 21 is being in contact with the inner peripheral wallof the outer vessel body 11. Therefore, in cases where the inner vesselbody 21 is moved with respect to the outer vessel body 11 in thedirection heading away from the outer vessel body 11, and the pressurein the enclosed space is thus set at the negative pressure, the state ofthe negative pressure is capable of being set more reliably. Also, sincethe O-ring 25 described above is provided, problems, such as the bloodconstituents leaking through a gap between the inner vessel body 21 andthe outer vessel body 11 to the exterior of the blood testing unit 10,are capable of being prevented.

Furthermore, with the blood testing unit 10, the O-ring 25 of the innervessel body 21 and the annular engagement section 17 of the outer vesselbody 11 are capable of engaging with each other in order to prevent theinner vessel body 21 from separating from the outer vessel body 11.Therefore, problems, such as the inner vessel body 21 and the outervessel body 11 separating by accident from each other, and the bloodconstituents leaking from the inner vessel body 21 and the outer vesselbody 11 to the exterior, are capable of being prevented. In thisembodiment, the O-ring 25 is utilized as the engagement section forengaging with the annular engagement section 17 of the outer vessel body11. Alternatively, a projecting section may be formed on the outerperipheral surface of the inner vessel body 21 and at a position lowerthan the position of the O-ring 25 in FIG. 2 and may be utilized as theengagement section of the inner vessel body 21.

Also, with the blood testing unit 10, the plurality of the differentkinds of the reagents, each of which is capable of undergoing thereaction with the blood plasma and/or the blood serum and forming thecolor as a result of the reaction, are supported at the differentpositions as the glucose detecting spots 24 a, 24 a and the uric aciddetecting spots 24 b, 24 b on the reagent layer 24. Therefore, in caseswhere the operation for supplying the blood plasma and/or the bloodserum to the reagent layer 24 is performed only one time, the bloodplasma and/or the blood serum is capable of being supplied to theplurality of the glucose detecting spots 24 a, 24 a and the uric aciddetecting spots 24 b, 24 b. Accordingly, the efficiency with which theblood test is performed is capable of being enhanced.

Further, in this embodiment of the blood testing unit 10, the reagentlayer 24 is provided with the multiple kinds of the glucose detectingspots 24 a, 24 a and the uric acid detecting spots 24 b, 24 b, which arecapable of undergoing reactions with different substances contained inthe blood plasma and/or blood serum. Also, the blood testing apparatus40, which is the first blood testing apparatus that employs the humoraltesting unit of the present invention, is constituted such that themeasuring light beams, each of which has a wavelength adapted to one ofthe reagents contained in the glucose detecting spots 24 a, 24 a and theuric acid detecting spots 24 b, 24 b, are irradiated successively to theglucose detecting spots 24 a, 24 a and the uric acid detecting spots 24b, 24 b. Therefore, with the blood testing apparatus 40, the tests withrespect to the different substances (in this case, glucose and uricacid) contained in the blood plasma and/or blood serum are capable ofbeing performed quickly. Alternatively, the blood testing apparatus 40may be constituted such that the measuring light beams are irradiatedsimultaneously to the multiple kinds of the glucose detecting spots 24a, 24 a and the uric acid detecting spots 24 b, 24 b, and theintensities of the light beams having been reflected from the glucosedetecting spots 24 a, 24 a and the uric acid detecting spots 24 b, 24 bare measured simultaneously. The alternative constitution of the bloodtesting apparatus 40 is advantageous for enhancing the efficiency of theblood test.

Also, with the blood testing apparatus 40, the two-dimensionalphotodetector 50, which detects the image of the reagent layer 24 of theblood testing unit 10, is employed as the means for detecting theoptical densities of the glucose detecting spots 24 a, 24 a and the uricacid detecting spots 24 b, 24 b. Further, the bar code 24 c attached tothe reagent layer 24 as illustrated in FIG. 3 is capable of being readout by the two-dimensional photodetector 50. Therefore, in cases wherethe photo detection signal S, which has been obtained from thetwo-dimensional photodetector 50, is processed appropriately in thesignal processing section 51, and the signal having been obtained fromthe processing is fed into the displaying section 52, the informationconcerning the blood testing unit 10, i.e. the production serial numberof the blood testing unit 10, the kind of the blood testing unit 10, orthe like, which information is represented by the bar code 24 c, iscapable of being displayed in the displaying section 52. Furthermore,correction of the test results is capable of being made in accordancewith correction information with respect to each of production lots ofblood testing units 10, 10, . . . , which correction information may berepresented by the bar code 24 c.

Besides the production serial number of the blood testing unit 10 andthe kind of the blood testing unit 10, the information represented bythe bar code 24 c may also contain information representing theproduction lot number, information representing the calibration curves,information for correction with respect to interfering substances, information for correction with respect to temperature, information forcorrection with respect to liquid quantity, and the like.

The bar code 24 c may be an ordinary one-dimensional bar code.Alternatively, the bar code 24 c may be a two-dimensional bar code, orthe like. Also, as the mark representing the information concerning theblood testing unit 10, a mark other than the bar code 24 c may beemployed.

In order for an accurate calculation of the optical density to be madefrom the photo detection signal S, which represents the intensity of thereflected light 43R having been reflected from each of the glucosedetecting spots 24 a, 24 a and the uric acid detecting spots 24 b, 24 b,in the manner described above, it is necessary to perform a correctionoperation, wherein values of the photo detection signal S detected incases where the reflectivity is set at 100% and 0% are obtained, and thephoto detection signal S, which represents the intensity of thereflected light 43R having been reflected from each of the glucosedetecting spots 24 a, 24 a and the uric acid detecting spots 24 b, 24 b,is corrected in accordance with the aforesaid values of the photodetection signal S. FIG. 19 is a perspective view showing a method forthe correction.

Specifically, in this case, a dummy unit 10W and a dummy unit 10K, eachof which has a shape identical with the shape of the blood testing unit10 and is capable of being accommodated in the unit receiving section 42of the blood testing apparatus 40, are utilized. The dummy unit 10Wcomprises an outer vessel body 11W, an inner vessel body 21W, and awhite plate 23W, which is located at the position corresponding to theposition of the reagent layer 24 of the blood testing unit 10. Also, thedummy unit 10K comprises an outer vessel body 11K, an inner vessel body21K, and a black plate 23K, which is located at the positioncorresponding to the position of the reagent layer 24 of the bloodtesting unit 10. Each of the dummy unit 10W and the dummy unit 10K isaccommodated in the unit receiving section 42 of the blood testingapparatus 40, and a photometric operation is performed in the samemanner as in the photometric operation for the blood testing unit 10. Inthis manner, the values of the photo detection signal S detected incases where the reflectivity is set at 100% and 0% are capable of beingobtained. The thus obtained values of the photo detection signal S maybe stored in storage means (not shown) and utilized for the correctingoperation described above.

As illustrated in FIG. 19, it is also possible to utilize a dummy unit10D comprising an outer vessel body 11D, an inner vessel body 21D, and abar code surface 23D, on which a bar code of the same type as the barcode 24 c shown in FIG. 3 has been recorded and which is located at theposition corresponding to the position of the reagent layer 24 of theblood testing unit 10. Specifically, for example, one piece of the dummyunit 10D may be accommodated in each pack containing a plurality ofblood testing units 10, 10, . . . Also, before each of the blood testingunits 10, 10, . . . contained in the pack is used for the blood test,the information represented by the bar code of the dummy unit 10D may beread out and stored in storage means (not shown). In such cases, theinformation represented by the bar code of the dummy unit 10D may beread from the storage means at the time of the photometric operation foreach of the blood testing unit 10, 10, . . . Also, the thus readinformation may be displayed in the manner described. Alternatively, theresults of the blood test may be corrected in accordance with the thusread information.

Each of the dummy unit 10W, the dummy unit 10K, and the dummy unit 10Dneed not necessarily have the shape identical with the shape of theblood testing unit 10. For example, a dummy unit 210D having a shapeillustrated in FIG. 20 may be utilized. The dummy unit 210D illustratedin FIG. 20 comprises a rod-shaped knob 221 and a circular plate 220,which is secured to one end of the rod-shaped knob 221. The surface ofthe circular plate 220 constitutes a bar code surface 223D, on which abar code 224 has been recorded. By way of example, in cases where thedummy unit 210D having the shape different from the shape of the bloodtesting unit 10 is utilized, the unit receiving section 42 of the bloodtesting apparatus 40 may be provided with a step-like area forsupporting the circular plate 220. In this manner, the dummy unit 210Dmay be supported in the unit receiving section 42 of the blood testingapparatus 40, such that the position of the bar code surface 223Dcoincides with the position of the reagent layer 24 of the blood testingunit 10.

In the blood testing apparatus 40 illustrated in FIG. 6, thetwo-dimensional photodetector 50 constituted of the CCD image sensor, orthe like, operates such that the intensity of the reflected light 43Rhaving been reflected from one detecting spot, which is among theglucose detecting spots 24 a, 24 a and the uric acid detecting spots 24b, 24 b of the reagent layer 24, is detected with a plurality of pixels(preferably, with at least 100 pixels). Specifically, with the pluralityof the pixels of the two-dimensional photodetector 50 described above, aplurality of independent light intensity detecting operations areperformed with respect to a plurality of subareas of the one detectingspot, which is among the glucose detecting spots 24 a, 24 a and the uricacid detecting spots 24 b, 24 b of the reagent layer 24. Each of theindependent light intensity detecting operations is performed for one ofthe plurality of the subareas of each of the glucose detecting spots 24a, 24 a and the uric acid detecting spots 24 b, 24 b. Also, the signalprocessing section 51 performs statistical processing on the results ofthe plurality of the independent light intensity detecting operationsperformed with respect to the plurality of the subareas of each of theglucose detecting spots 24 a, 24 a and the uric acid detecting spots 24b, 24 b. From the statistical processing, a light intensity value, whichis representative of each of the glucose detecting spots 24 a, 24 a andthe uric acid detecting spots 24 b, 24 b, is obtained. The thus obtainedlight intensity value, which is representative of each of the glucosedetecting spots 24 a, 24 a and the uric acid detecting spots 24 b, 24 b,is taken as the intensity of the reflected light 43R having beenreflected from each of the glucose detecting spots 24 a, 24 a and theuric acid detecting spots 24 b, 24 b and is utilized for the calculationof the optical density described above.

As the statistical processing described above, for example, processingfor calculating a mean value, processing for calculating a median value,or processing for calculating a normal distribution of the detectedlight intensity values and calculating a mean value of the detectedlight intensity values, which fall within the range of ±2SD (where SDrepresents the standard deviation) around a detected light intensityvalue that is associated with the maximum frequency of occurrence, maybe employed.

In the manner described above, the light intensity value, which isrepresentative of each of the glucose detecting spots 24 a, 24 a and theuric acid detecting spots 24 b, 24 b, is obtained. Also, the opticaldensity of each detecting spot is calculated in accordance with the thusobtained light intensity value. Therefore, in cases where nonuniformityoccurs with the reaction of the reagent with the blood plasma and/or theblood serum within each of the glucose detecting spots 24 a, 24 a andthe uric acid detecting spots 24 b, 24 b, or in cases where fine dust,or the like, is present within each of the detecting spots, adverseeffects of specific results of the light intensity detection due to thenonuniformity in reaction, the fine dust, or the like, are capable ofbeing eliminated, and the blood test is capable of being performedaccurately.

As described above, in the blood testing apparatus 40, the region, forwhich one pixel of the two-dimensional photodetector 50 performs thelight intensity detection, is taken as one subarea of each of theglucose detecting spots 24 a, 24 a and the uric acid detecting spots 24b, 24 b. Alternatively, a region, for which a group of a plurality ofpixels of the two-dimensional photodetector 50 perform the lightintensity detection, may be taken as one subarea of each of the glucosedetecting spots 24 a, 24 a and the uric acid detecting spots 24 b, 24 b.Specifically, for example, a region, for which a group of four adjacentpixels of the two-dimensional photodetector 50 perform the lightintensity detection, may be taken as one subarea of each of the glucosedetecting spots 24 a, 24 a and the uric acid detecting spots 24 b, 24 b.Also, for example, a mean value of the light intensity values havingbeen detected with the group of the four adjacent pixels may besubjected to the statistical processing described above.

Also, in the blood testing apparatus 40 illustrated in FIG. 6, themeasuring light 43 irradiated to each of the glucose detecting spots 24a, 24 a and the uric acid detecting spots 24 b, 24 b is the lightcomponent, which has been obtained through light separation so as tohave the wavelength corresponding to the reagent contained in each ofthe glucose detecting spots 24 a, 24 a and the uric acid detecting spots24 b, 24 b. Therefore, the light beams having been reflected from theglucose detecting spots 24 a, 24 a and the uric acid detecting spots 24b, 24 b are capable of being detected by being clearly discriminatedfrom one another. Therefore, the blood tests with respect to a pluralityof test purposes are capable of being performed accurately.

Further, in the blood testing apparatus 40 illustrated in FIG. 6, theirradiation of the measuring light 43 to the reagent layer 24 and thedetection of the intensity of the reflected light 43R having beenreflected from the reagent layer 24 are performed from the side of onesurface of the reagent layer 24 opposite to the other surface of thereagent layer 24, on which other surface the blood plasma and/or theblood serum has been supplied to the reagent layer 24. Therefore, thelight intensity measuring section 47 for the detection of the reflectedlight 43R and the light guide member 45 do not interfere with the bloodconstituent separating membrane 16 for supplying the blood plasma and/orthe blood serum. Accordingly, flexibility in layout of the lightintensity measuring section 47 and the light guide member 45 is capableof being kept high. Particularly, in this case, the reagent layer 24 isaccommodated in the closed vessel constituted of the outer vessel body11 and the inner vessel body 21, and the layout of the light intensitymeasuring section 47 and the light guide member 45 is ordinarily noteasy. Therefore, the effect of keeping the flexibility in layout of thelight intensity measuring section 47 and the light guide member 45 highis markedly advantageous in practice. The effect described above is alsoobtained with the blood testing apparatuses shown in FIG. 6, FIG. 8,FIG. 9, and FIG. 10, which will be described later.

A blood testing unit 10A, which is a second embodiment of the bloodtesting unit in accordance with the present invention, will be describedhereinbelow with reference to FIG. 7. In FIG. 7 (and those that follow),similar elements are numbered with the same reference numerals withrespect to FIG. 1 to FIG. 6.

The blood testing unit 10A illustrated in FIG. 7 is constitutedbasically in the same manner as that in the blood testing unit 10 shownin FIG. 1 to FIG. 6, except that the reagent layer 24 is not formed onthe side of an inner vessel body 21 and is formed on the side of anouter vessel body 11. The reagent layer 24 is formed such that thereagent layer 24 is in contact with the back surface of the bloodconstituent separating membrane 16 located within the outer vessel body11, which back surface is opposite to the surface that faces the rubberfilm 15.

In cases where the blood testing unit 10A constituted in the mannerdescribed above is utilized, the blood test is capable of beingperformed basically in the same manner as that described above by use ofthe blood testing apparatus 40 shown in FIG. 5 and FIG. 6. However, inthis case, after the whole blood 31 has been introduced into the bloodtesting unit 10A, the outer vessel body 11 need not necessarily bepushed toward the inner vessel body 21, and the blood plasma and/or theblood serum having been separated by the blood constituent separatingmembrane 16 from the whole blood 31 is capable of spreading through thereagent layer 24. Specifically, with the blood testing unit 10A, thesupply of the blood plasma and/or the blood serum to the reagent layer24 is performed more quickly than with the blood testing unit 10described above.

A blood testing unit 10B, which is a third embodiment of the bloodtesting unit in accordance with the present invention, and a bloodtesting apparatus 40A, which is a second blood testing apparatus thatemploys the humoral testing unit of the present invention, will bedescribed hereinbelow with reference to FIG. 8. The blood testing unit10B illustrated in FIG. 8 is constituted basically in the same manner asthat in the blood testing unit 10 shown in FIG. 1 to FIG. 6, except thata bottom wall 23B of an inner vessel body 21 is not formed at an endportion of the inner vessel body 21 and is formed at an intermediatearea of the inner vessel body 21.

Also, the blood testing apparatus 40A illustrated in FIG. 8 isconstituted basically in the same manner as that in the blood testingapparatus 40 shown in FIG. 6, except that a light guide member 45 isformed such that a light radiating end portion of the light guide member45 is capable of passing through an opening 42 b of the bottom plate ofthe unit receiving section 42 and entering into the inner vessel body 21of the blood testing unit 10B. A light radiating end face of the lightguide member 45 comes into contact with the bottom wall 23B of the innervessel body 21. Therefore, the distance between the objective lens 48 ofthe light intensity measuring section 47 and the reagent layer 24, thedistance between the image forming lens 49 of the light intensitymeasuring section 47 and the reagent layer 24, and the distance betweenthe two-dimensional photodetector 50 of the light intensity measuringsection 47 and the reagent layer 24 are kept at predetermined values.

In cases where the blood testing unit 10B and the blood testingapparatus 40A having the constitutions described above are utilized, theblood test is capable of being performed basically in the same manner asthat in cases where the blood testing unit 10 and the blood testingapparatus 40 shown in FIG. 6 are utilized.

A blood testing apparatus 40B, which is a third blood testing apparatusthat employs the humoral testing unit of the present invention, will bedescribed hereinbelow with reference to FIG. 9. The blood testingapparatus 40B illustrated in FIG. 9 is constituted basically in the samemanner as that in the blood testing apparatus 40A shown in FIG. 8,except for a constitution of a light intensity measuring section 55.Specifically, the light intensity measuring section 55 comprises thetwo-dimensional photodetector 50 and an image forming lens 56. Also, inthe blood testing apparatus 40B, the light radiating end face of thelight guide member 45 comes into contact with the bottom wall 23B of theinner vessel body 21. Therefore, the distance between the image forminglens 56 of the light intensity measuring section 55 and the reagentlayer 24 and the distance between the two-dimensional photodetector 50of the light intensity measuring section 55 and the reagent layer 24 arekept at predetermined values. In the blood testing apparatus 40B, as theblood testing unit 10B, the blood testing unit 10B illustrated in FIG. 8is utilized.

In cases where the blood testing unit 10B and the blood testingapparatus 40B having the constitutions described above are utilized, theblood test is capable of being performed basically in the same manner asthat in cases where the blood testing unit 10 and the blood testingapparatus 40 shown in FIG. 6 are utilized.

A blood testing apparatus 40 c, which is a fourth blood testingapparatus that employs the humoral testing unit of the presentinvention, will be described hereinbelow with reference to FIG. 10. Theblood testing apparatus 40C illustrated in FIG. 10 is constitutedbasically in the same manner as that in the blood testing apparatus 40shown in FIG. 6, except that a light intensity measuring section 47C hasa shape longer than the shape of the light intensity measuring section47, and a rear end portion of the light intensity measuring section 47Cextends from the light guide member 45 to the exterior. In the lightintensity measuring section 47C, as the blood testing unit 10, the bloodtesting unit 10 illustrated in FIG. 6 is utilized.

In cases where the blood testing apparatus 40C constituted in the mannerdescribed above is utilized, the blood test is capable of beingperformed basically in the same manner as that in cases where the bloodtesting apparatus 40 shown in FIG. 6 is utilized.

A blood testing unit 60, which is a fourth embodiment of the bloodtesting unit in accordance with the present invention, will be describedhereinbelow with reference to FIG. 11. The blood testing unit 60illustrated in FIG. 11 comprises a rectangular box-shaped outer vesselbody 61, which has a bottom wall at an end portion and is made from atransparent member. The blood testing unit 60 also comprises arectangular box-shaped inner vessel body 62, which is combined with theouter vessel body 61 for slide movement within the outer vessel body 61.The blood testing unit 60 further comprises a rubber film 65, which actsas the blood introducing section and closes a circular opening 64 formedthrough a side wall 63 of the outer vessel body. The blood testing unit60 still further comprises a plate-shaped blood constituent separatingmembrane 66, which is located within the outer vessel body 61 so as toextend along the axial direction of the outer vessel body 61. The bloodtesting unit 60 also comprises a plate-shaped reagent layer 67, which issecured to a lower surface of the blood constituent separating membrane66 in FIG. 11. In FIG. 11, as an aid in facilitating the explanation,the reagent layer 67 is illustrated at a position spaced away from theblood constituent separating membrane 66.

As in the cases of the outer vessel body 11 and the inner vessel body 21of the blood testing unit 10 illustrated in FIG. 6, the outer vesselbody 61 and the inner vessel body 62 of the blood testing unit 60 definean enclosed space at the interior. Also, in cases where the inner vesselbody 62 is moved in the direction heading away from the outer vesselbody 61 (i.e., toward the right-hand side in FIG. 11), the pressure inthe enclosed space is set at the negative pressure.

The blood constituent separating membrane 66 is constituted basically inthe manner as that in the blood constituent separating membrane 16 ofthe blood testing unit 10 illustrated in FIG. 6, except that the bloodconstituent separating membrane 66 has a thickness larger than thethickness of the blood constituent separating membrane 16 and has theplate-like shape.

By way of example, the reagent layer 67 comprises a plate-shapednitrocellulose porous membrane, which has a pore diameter of 0.45 μm andacts as the support. Also, detecting spots 67 a, 67 b, 67 c, 67 d, 67 eand 67 f, each of which contain one of a plurality of different kinds(by way of example, six kinds) of reagents, have been formed with aspotting process on the nitrocellulose porous membrane. Each of theplurality of the different kinds of the reagents is capable ofundergoing a reaction with one of a plurality of different substancescontained in the blood plasma and/or the blood serum and is capable offorming a color as a result of the reaction. As described above, thereagent layer 67 is secured to the blood constituent separating membrane66. Therefore, the reagent layer 67 also extends along the axialdirection of the outer vessel body 61.

How a blood test is performed by use of the blood testing unit 60described above will be described hereinbelow. Firstly, how an operationfor taking a blood sample is performed will be described hereinbelow. Inorder for the blood sample to be taken, the inner vessel body 62 isoperated in the manner described above, and the pressure within theenclosed space in the blood testing unit 60 is thus set at the negativepressure. In this state, one tip of the blood sampling needle 30, whoseother tip has been stuck in, for example, the upper arm of a human body,is stuck through the rubber film 65 of the outer vessel body 61 into theenclosed space described above. As a result, since the pressure withinthe enclosed space has been set at the negative pressure, the wholeblood 31 passes through the blood sampling needle 30 and is thusintroduced into the enclosed space. As illustrated in FIG. 11, the wholeblood 31 spreads over the blood constituent separating membrane 66.Solid constituents of the whole blood 31 are caught on the surface ofthe blood constituent separating membrane 66, and the blood plasmaand/or the blood serum passes through the blood constituent separatingmembrane 66. The blood plasma and/or the blood serum, which has passedthrough the blood constituent separating membrane 66, spreads over thereagent layer 67. Each of the detecting spots 67 a to 67 f of thereagent layer 67 undergoes the reaction with one of the specificsubstances, which are contained in the blood plasma and/or the bloodserum and are to be tested. As a result of the reaction, each of thedetecting spots 67 a to 67 f forms the color.

The inner vessel body 62 of the blood testing unit 60 is provided withthe air introducing aperture 26, and the sealing member 27 for closingthe air introducing aperture 26 is adhered to the inner vessel body 62.Therefore, with the air introducing aperture 26 and the sealing member27, the same effects as those described above are capable of beingobtained.

How the optical densities of the detecting spots 67 a to 67 f aremeasured will be described hereinbelow. FIG. 12 is a perspective viewshowing a major part of a blood testing apparatus 40D, which is a fifthblood testing apparatus that employs the humoral testing unit of thepresent invention. In the blood testing apparatus 40D, the blood testingunit 60 is subjected to the photometric operation. As illustrated inFIG. 12, the blood testing apparatus 40D comprises a pair of light guidemember 70, 70 for irradiating the measuring light 43 to the detectingspots 67 a, 67 b, 67 c, 67 d, 67 e, and 67 f of the reagent layer 67from the side of a back surface (i.e., the lower surface in FIG. 11) ofthe reagent layer 67 of the blood testing unit 60. The blood testingapparatus 40D also comprises six distributed index lenses 71 a, 71 b, 71c, 71 d, 71 e, and 71 f, which are located at positions corresponding tothe positions of the detecting spots 67 a, 67 b, 67 c, 67 d, 67 e, and67 f. The blood testing apparatus 40D further comprises thetwo-dimensional photodetector 50, such as a CCD image sensor, which islocated so as to stand facing all of the distributed index lenses 71 a,71 b, 71 c, 71 d, 71 e, and 71 f.

One side wall of the outer vessel body 61 of the blood testing unit 60intervenes between the blood testing apparatus 40D and the reagent layer67. In FIG. 12, as an aid in facilitating the explanation, the one sidewall of the outer vessel body 61 is not shown.

In the blood testing apparatus 40D having the constitution describedabove, when the measuring light 43 is irradiated to the reagent layer67, light beams having been reflected from the detecting spots 67 a, 67b, 67 c, 67 d, 67 e, and 67 f of the reagent layer 67 are efficientlycollected respectively by the distributed index lenses 71 a, 71 b, 71 c,71 d, 71 e, and 71 f. Therefore, the intensity of the reflected lightbeam is measured with respect to each of the distributed index lenses 71a to 71 f, i.e. with respect to each of the detecting spots 67 a to 67f. Accordingly, with the blood testing apparatus 40D, the opticaldensity of each of the detecting spots 67 a to 67 f having formed thecolors is capable of being detected in accordance with the photodetection signal S, which is obtained from the two-dimensionalphotodetector 50.

In order for the concentrations of the specific substances, which havereacted with the detecting spots 67 a to 67 f, to be calculated from theoptical densities of the detecting spots 67 a to 67 f, which opticaldensities change with the passage of time, basically the same techniqueas the technique utilizing the calibration curves, which technique isemployed in the blood testing apparatus 40 of FIG. 6, may be employed.

Also, in the blood testing apparatus 40D, described above, theirradiation of the measuring light 43 to the reagent layer 67 and thedetection of the intensities of the light beams having been reflectedfrom the reagent layer 67 are performed from the side of the backsurface of the reagent layer 67 of the blood testing unit 60 opposite tothe other surface of the reagent layer 67, which other surface faces theblood constituent separating membrane 66 for supplying the blood plasmaand/or the blood serum to the reagent layer 67 as illustrated in FIG.11. Therefore, the light guide member 70, 70, the distributed indexlenses 71 a to 71 f, and the two-dimensional photodetector 50 do notinterfere with the blood constituent separating membrane 66.Accordingly, the layout of the light guide member 70, 70, thedistributed index lenses 71 a to 71 f, and the two-dimensionalphotodetector 50 becomes easy. Particularly, in the blood testingapparatus 40D, wherein the distributed index lenses 71 a to 71 f arelocated such that each of the distributed index lenses 71 a to 71 fcorresponds to one of the detecting spots 67 a to 67 f, the flexibilityin layout of the distributed index lenses 71 a to 71 f is ordinarily nothigh. Therefore, the effect of keeping the layout of the light guidemember 70, 70, the distributed index lenses 71 a to 71 f, and thetwo-dimensional photodetector 50 easy is markedly advantageous inpractice. The effect described above is also obtained with the bloodtesting apparatuses shown in FIG. 13, FIG. 18, and FIG. 22, which willbe described later.

Further, in the blood testing apparatus 40D, the distributed indexlenses 71 a to 71 f are located such that each of the distributed indexlenses 71 a to 71 f faces one of the detecting spots 67 a to 67 f.Therefore, problems, such as the measuring light having been scatteredby areas of the reagent layer 67 other than the detecting spots 67 a to67 f being detected by the two-dimensional photodetector 50, and theaccuracy of the blood test being affected adversely, are capable ofbeing prevented.

Experiments were conducted for confirmation of the effect describedabove. In the experiments, an aqueous Bromophenol Blue solution actingas a reagent was spotted onto a nitrocellulose membrane, and a reagentlayer was thus formed. Diameters of detecting spots were set at 500 μm,and pitches of the detecting spots were set at 1 mm, such that thedetecting spots having formed colors may be arrayed at predeterminedintervals. In this manner, four detecting spots (i.e., two detectingspots arrayed in the vertical direction×two detecting spots arrayed inthe horizontal direction) were formed. Halogen lamps were employed aslight sources for producing measuring light beams, and R-60 (supplied byHoya Corp.) was employed as optical filters. By use of the halogen lampsand the optical filters, the measuring light beams were irradiated tothe detecting spots described above. Light beams having been reflectedfrom the detecting spots were collected by distributed index lenses,each of which was located with respect to one of the detecting spots,and the intensities of the reflected light beams were detected. A meanvalue of the thus detected intensities of the light beams having beenreflected from the detecting spots was taken as 100. Also, an experimentwas conducted by use of a unit for experiment, in which the areas of thereagent layer 67 other than the detecting spots 67 a to 67 f had beenset as black areas. In the experiment using the unit for experiment, amean value of the detected intensities of the light beams having beenreflected from the detecting spots was equal to 100. If the lightcollecting optical system comprising the distributed index lenses alsocollected the light having been scattered from the areas of the reagentlayer 67 other than the detecting spots 67 a to 67 f, the mean value ofthe detected intensities of the light beams having been reflected fromthe detecting spots would be smaller than 100 in the experiment usingthe unit for experiment. However, since the mean value of the detectedintensities of the light beams having been reflected from the detectingspots was equal to 100 in the experiment using the unit for experiment,it was confirmed that the light collecting optical system did notcollect the scattered light. The effect described above is also obtainedin cases where a one-dimensional photodetector is employed as thephotodetector in lieu of the two-dimensional photodetector 50.

A blood testing apparatus 40F, which is a sixth blood testing apparatusthat employs the humoral testing unit of the present invention, will bedescribed hereinbelow with reference to FIG. 13. The blood testingapparatus 40F illustrated in FIG. 13 is constituted for the cases wherea reagent layer 67F is provided with a plurality of (by way of example,four) detecting spots 67 a, 67 b, 67 c, and 67 d, which are arrayed inone row. The blood testing apparatus 40F is constituted basically in thesame manner as that in the blood testing apparatus 40D illustrated inFIG. 12, except that four distributed index lenses 71 a, 71 b, 71 c, and71 d are arrayed in one row, and a one-dimensional photodetector 72constituted of a CCD linear sensor, or the like, is employed as thephotodetector.

In the blood testing apparatus 40F, when the measuring light 43 isirradiated to the reagent layer 67F, the light beams having beenreflected from the detecting spots 67 a, 67 b, 67 c, and 67 d of thereagent layer 67F are efficiently collected respectively by thedistributed index lenses 71 a, 71 b, 71 c, and 71 d. Therefore, theintensity of the reflected light beam is measured with respect to eachof the distributed index lenses 71 a to 71 d, i.e. with respect to eachof the detecting spots 67 a to 67 d. Accordingly, with the blood testingapparatus 40F, the optical density of each of the detecting spots 67 ato 67 d having formed the colors is capable of being detected inaccordance with the photo detection signal S, which is obtained from theone-dimensional photodetector 72.

In order for the concentrations of the specific substances, which havereacted with the detecting spots 67 a to 67 d, to be calculated from theoptical densities of the detecting spots 67 a to 67 d, which opticaldensities change with the passage of time, basically the same techniqueas the technique utilizing the calibration curves, which technique isemployed in the blood testing apparatus 40 of FIG. 6, may be employed.

A blood testing unit 80, which is a fifth embodiment of the bloodtesting unit in accordance with the present invention, will be describedhereinbelow with reference to FIG. 14. The blood testing unit 80illustrated in FIG. 14 is constituted basically in the same manner asthat in the blood testing unit 60 shown in FIG. 11, except that a bloodconstituent separating membrane 66G is located in parallel with a bottomwall 68 of an outer vessel body 61G, the opening 64 is formed throughthe bottom wall 68, and a rod-shaped reagent layer 67G extends along theaxial direction of the outer vessel body 61G. By way of example, thereagent layer 67G is provided with five detecting spots 67 a, 67 b, 67c, 67 d, and 67 e, which are arrayed in one row.

With the blood testing unit 80, the blood sampling needle 30 is stuckthrough the rubber film 65, which closes the opening 64, and the wholeblood is introduced through the blood sampling needle 30 into theenclosed space in the outer vessel body 61G. The whole blood having beenintroduced into the outer vessel body 61G spreads over the bloodconstituent separating membrane 66G. The solid constituents of the wholeblood are caught on the surface of the blood constituent separatingmembrane 66G, and the blood plasma and/or the blood serum passes throughthe blood constituent separating membrane 66G. The blood plasma and/orthe blood serum, which has passed through the blood constituentseparating membrane 66G, spreads over the reagent layer 67G in thelongitudinal direction of the reagent layer 67G. Each of the detectingspots 67 a to 67 e of the reagent layer 67G undergoes the reaction withone of the specific substances, which are obtained in the blood plasmaand/or the blood serum and are to be tested. As a result of thereaction, each of the detecting spots 67 a to 67 e forms the color.

In order for the optical densities of the detecting spots 67 a to 67 ehaving formed the colors to be detected, a blood testing apparatushaving a constitution basically similar to the constitution of, forexample, the blood testing apparatus 40F shown in FIG. 13 may beutilized.

The inner vessel body 62 of the blood testing unit 80 is provided withthe air introducing aperture 26, and the sealing member 27 for closingthe air introducing aperture 26 is adhered to the inner vessel body 62.Therefore, with the air introducing aperture 26 and the sealing member27, the same effects as those described above are capable of beingobtained.

FIG. 15 is a plan view showing a different embodiment of a reagent layer124 constituting the blood testing unit in accordance with the presentinvention. In this embodiment, the area of the reagent layer 124, whicharea is other than the detecting spots 24 a, 24 a and the detectingspots 24 b, 24 b carrying the reagent, is formed as a black surface124B. In cases where the reagent layer 124 is formed in this manner,problems, such as the measuring light having been scattered by the areaof the reagent layer, which area is other than the detecting spots 24 a,24 a and the detecting spots 24 b, 24 b carrying reagents, beingdetected by the photo detecting means, and the accuracy of the bloodtest being affected adversely, are capable of being prevented. In lieuof the area of the reagent layer 124, which area is other than thedetecting spots 24 a, 24 a and the detecting spots 24 b, 24 b carryingthe reagents, being formed as the black surface 124B, the area may beformed as a dark surface of a color close to black, or a mirror surface.In such cases, the same effect as that described above is capable ofbeing obtained.

Experiments were conducted for confirmation of the effect describedabove. In the experiments, an aqueous Bromophenol Blue solution actingas a reagent was spotted onto a nitrocellulose membrane, and a reagentlayer was thus formed. Diameters of detecting spots were set at 500 μm,and pitches of the detecting spots were set at 1 mm, such that thedetecting spots having formed colors may be arrayed at predeterminedintervals. In this manner, four detecting spots (i.e., two detectingspots arrayed in the vertical direction x two detecting spots arrayed inthe horizontal direction) were formed. A halogen lamp was employed as alight source for producing the measuring light, and R-60 (supplied byHoya Corp.) was employed as an optical filter. By use of the halogenlamp and the optical filter, the measuring light was irradiated to thedetecting spots described above. Light having been reflected from thedetecting spots was guided to a CCD image sensor. A mean value of thedetected intensities of the light having been reflected from thedetecting spots was taken as 100. Also, an experiment was conducted byuse of a reagent layer, in which the area of the reagent layer otherthan the detecting spots had been set as a black area. In the experimentusing the thus set reagent layer, a mean value of the detectedintensities of the light having been reflected from the detecting spotswas equal to 97. From the result of the experiments described above, itwas confirmed that the adverse effects of the scattered light comingfrom the area other than the detecting spots could be suppressed.

FIG. 16 is a perspective view showing a further different example of areagent layer 167 constituting the blood testing unit in accordance withthe present invention. In this example of the reagent layer 167,detecting areas 167 a, 167 b, 167 c, and 167 d carrying the reagent areformed in a long stripe-like shape.

A blood testing unit 110, which is an sixth embodiment of the bloodtesting unit in accordance with the present invention, will be describedhereinbelow with reference to FIG. 17. The blood testing unit 110illustrated in FIG. 17 is constituted basically in the same manner asthat in the blood testing unit 10 shown in FIG. 1, except that the bloodtesting unit 110 is provided with locking means for keeping the statesof an outer vessel body 11 and a inner vessel body 21 when the pressurein the enclosed space defined at the interior by the outer vessel body11 and a inner vessel body 21 has been set at the negative pressure. Thelocking means comprises an L-shaped engagement groove 111, which isformed in the inner peripheral wall surface of the outer vessel body 11,and an engagement protrusion 121, which protrudes from the outerperipheral wall surface of the inner vessel body 21 and is accommodatedwithin the engagement groove 111.

In cases where the blood testing unit 110 is utilized for the bloodtest, the inner vessel body 21 is pulled in the direction heading awayfrom the outer vessel body 11, i.e. downwardly in FIG. 17. (At thistime, the engagement protrusion 121 moves downwardly in a verticalgroove area of the outer vessel body 11.) In this manner, the pressurein the enclosed space defined at the interior by the outer vessel body11 and the inner vessel body 21 is set at the negative pressure.Thereafter, the inner vessel body 21 is rotated slightly in thedirection indicated by the arrow T in FIG. 17. As a result, theengagement protrusion 121 is thus guided into a horizontal groove areaof the outer vessel body 11, and the inner vessel body 21 is preventedfrom moving in the axial direction of the inner vessel body 21.Therefore, problems, such as the outer vessel body 11 and the innervessel body 21 naturally returning to the original states, i.e. thepressure in the enclosed space returning from the negative pressure tothe atmospheric pressure, are capable of being prevented. Accordingly,the outer vessel body 11 and the inner vessel body 21 need not be heldwith the tips of the fingers of the person in charge of the blood testsuch that the two vessel bodies do not return to the original states.Accordingly, the operation for introducing the blood sample into theclosed vessel is capable of being performed easily.

A seventh blood testing apparatus that employs the humoral testing unitof the present invention will be described hereinbelow with reference toFIG. 18. FIG. 18 is a front view showing a light receiving opticalsystem of the seventh blood testing apparatus. The seventh blood testingapparatus is utilized for performing the blood test by use of, forexample, the blood testing unit having the reagent layer 67F shown inFIG. 13. In this embodiment, as the light collecting optical system forcollecting the beams of the reflected light 43R, which beams have beenreflected from the detecting spots 67 a, 67 b, 67 c, and 67 d, andguiding the collected beams of the reflected light 43R to theone-dimensional photodetector 72, a lens array 170 comprising aplurality of distributed index lenses 171, 171, . . . , which arearrayed in one row, is employed.

With the constitution shown in FIG. 18, a beam of the reflected light43R, which beam has been reflected from one of the detecting spots 67 a,67 b, 67 c, and 67 d, is efficiently collected by a group of a pluralityof (in this example, four) distributed index lenses 171, 171, . . . andguided to the one-dimensional photodetector 72.

In the constitution shown in FIG. 18, as described above, the beams ofthe reflected light 43R are collected by the plurality of the lenses,which are arrayed in the one-dimensional direction. Alternatively, thebeams of the reflected light 43R may be collected by a plurality oflenses, which are arrayed in two-dimensional directions.

An eighth blood testing apparatus that employs the humoral testing unitof the present invention will be described hereinbelow with reference toFIG. 21. FIG. 21 is a perspective view showing a light sending opticalsystem of the eighth blood testing apparatus. The eighth blood testingapparatus comprises four light emitting diodes 244 a, 244 b, 244 c, and244 d, which produce the measuring light beam 43, 43, . . . havingdifferent wavelengths. The measuring light beam 43, which has beenproduced by the light emitting diode 244 a, is collimated by acollimator lens 245 a, and the thus collimated measuring light beam 43is transmitted through a band pass filter 246 a. In the same manner, themeasuring light beams 43, 43, 43, which have been produced by the lightemitting diodes 244 b, 244 c, and 244 d, are collimated respectively bycollimator lenses 245 b, 245 c, and 245 d, and the thus collimatedmeasuring light beams 43, 43, 43 are transmitted respectively throughband pass filters 246 b, 246 c, and 246 d.

The light emitting diodes 2 ⁴ 4 a, 244 b, 244 c, and 244 d, thecollimator lenses 245 a, 245 b, 245 c, and 245 d, and the band passfilters 246 a, 246 b, 246 c, and 246 d are supported on a moving base240. The moving base 240 is capable of being moved by driving means 250in the array direction of the light emitting diodes 244 a, 244 b, 244 c,and 244 d, i.e. in the direction indicated by the arrow M in FIG. 21.Also, the eighth blood testing apparatus comprises the light guidemember 45 for guiding the measuring light 43 in the same manner as thatin the light guide member 45 illustrated in FIG. 6. A chopper 251 islocated in front of the light entry end face of the light guide member45.

With the constitution illustrated in FIG. 21, the moving base 240 ismoved, and one of the four light emitting diodes 244 a, 244 b, 244 c,and 244 d is selectively located at the position which faces the lightentry end face of the light guide member 45. In this manner, the movingbase 240 is intermittently moved at predetermined time intervals, andthe four measuring light beams 43, 43, . . . having differentwavelengths are successively irradiated from the light radiating endface of the light guide member 45 to the reagent layer of the bloodtesting unit (not shown in FIG. 21).

With the constitution illustrated in FIG. 21, the chopper 251 is capableof being rotated and set in a state in which the chopper 251 blocks themeasuring light 43. Therefore, when the chopper 251 is being set in thisstate, the operation for storing the photo detection signal S, which isobtained from a photodetector (not shown in FIG. 21), e.g. thetwo-dimensional photodetector 50 illustrated in FIG. 6, may beperformed. The thus stored photo detection signal S is capable of beingutilized as the photo detection signal, which is obtained in cases wherethe reflectivity of the reagent layer with respect to the measuringlight 43 is 0%. Therefore, the thus stored photo detection signal S iscapable of being utilized for the correction of the optical densitydescribed above.

A blood testing apparatus 40H, which is a ninth blood testing apparatusthat employs the humoral testing unit of the present invention, will bedescribed hereinbelow with reference to FIG. 22. The blood testingapparatus 40H illustrated in FIG. 22 is constituted basically in thesame manner as that in the blood testing apparatus 40F illustrated inFIG. 13, except that, in lieu of the single, comparatively large lightguide member 70, four light guide members 70 a, 70 b, 70 c, and 70 d areutilized. The four light guide members 70 a, 70 b, 70 c, and 70 dirradiate the measuring light beams 43, 43, . . . respectively to thefour detecting spots 67 a, 67 b, 67 c, and 67 d of the reagent layer67F.

The light guide members 70 a, 70 b, 70 c, and 70 d constitute fourindependent light sending systems. Therefore, with the constitutionillustrated in FIG. 22, the measuring light beams, which have beenseparated from one another such that each of the measuring light beamshas a wavelength adapted to one of the reagents contained in the fourdetecting spots 67 a, 67 b, 67 c, and 67 d, are capable of beingirradiated to the detecting spots 67 a, 67 b, 67 c, and 67 d as theindependent measuring light irradiating operations. Accordingly, theaccuracy of the blood test is capable of being enhanced.

Elements constituting the blood testing unit in accordance with thepresent invention will hereinbelow be described in more detail. As forseveral elements, how the elements are produced, and the like, will alsobe described hereinbelow.

Firstly, an example of the porous structure material constituting thereagent layer will be described hereinbelow. In this example, the porousstructure material was formed with a calendering process from anitrocellulose membrane or a polysulfone membrane. Specifically, a 100μm-thick stainless steel flat plate having 64 apertures (i.e., eightapertures arrayed in the vertical direction x eight apertures arrayed inthe horizontal direction), which had a diameter of 300 μm and werearrayed such that the distance between center points of adjacentapertures was equal to 500 μm, was prepared. A nitrocellulose membranehaving a pore diameter of 15 μm (STHF, supplied by MilliporeCorporation) was then hot-pressed to the stainless steel flat plate at atemperature of 140° C. and a pressure of 500 Kg/cm² for two minutes. Inthis manner, the porous structure material was formed in each of theapertures of the stainless steel flat plate. At the region of thenitrocellulose membrane located on the side outward from the aperturesof the stainless steel flat plate, the porous structure of thenitrocellulose membrane was lost due to the hot pressing, and the whitemembrane changed to a transparent film. In this manner, a structure (abarrier), which was not permeable to water, was formed on the sideoutward from the apertures of the stainless steel flat plate.

In lieu of the nitrocellulose membrane described above, a nitrocellulosemembrane having a pore diameter of 0.45 μm (HA, supplied by MilliporeCorporation) may be employed. As another alternative, a polysulfonemembrane having a pore diameter falling within the range of 0.5 μm to 50μm (minimum pore diameter: 1 μm to 2 μm, supplied by Fuji Photo FilmCo., Ltd.) may be employed in lieu of the nitrocellulose membranedescribed above. As a further alternative, a porous membrane constitutedof acetyl cellulose, cellulose, nylon, or the like, may be employed inlieu of the nitrocellulose membrane described above. Further, in lieu ofthe stainless steel flat plate described above, a metal plateconstituted of nickel, copper, silver, gold, platinum, or the like, maybe employed. As another alternative, a resin plate constituted of Teflon(trade name), a polystyrene, a polyethylene, or the like, may beemployed in lieu of the stainless steel flat plate described above.

The porous structure material formed in the manner described above iscapable of being utilized for the formation of the reagent layer 24, 67,67F, or 67G in each of the embodiments described above.

A different example of the porous structure material constituting thereagent layer will be described hereinbelow. In this example, the porousstructure material was formed with a coating process. Specifically, a100 μm-thick stainless steel flat plate having 64 apertures (i.e., eightapertures arrayed in the vertical direction x eight apertures arrayed inthe horizontal direction), which had a diameter of 300 μm and werearrayed such that the distance between center points of adjacentapertures was equal to 500 μm, was prepared. Styrene-butadiene rubberwas then coated on the stainless steel flat plate and dried. Thereafter,a nitrocellulose solution (a 10 wt % solution in ethyl acetate) wascoated on the stainless steel flat plate. The nitrocellulose solution,which remained at the region other than the apertures of the stainlesssteel flat plate, was then squeezed out, and the nitrocellulose solutionwithin the apertures was dried. In this manner, the porous structurematerial was formed in each of the apertures of the stainless steel flatplate.

The porous structure material formed in the manner described above iscapable of being utilized for the formation of the reagent layer 24, 67,67F, or 67G in each of the embodiments described above.

In order for the reagent to be supported on the porous structurematerial described above, for example, a predetermined amount, e.g.approximately 1 nl(nanoliter), of the reagent may be spotted onto theporous structure material by use of a commercially available spotter,and the spotted reagent may then be dried to form a detecting spot.

Also, in cases where the detecting spot is formed in the mannerdescribed above, a barrier should preferably be formed previously, suchthat the water-soluble reagent may not permeate through the area otherthan the area acting as the detecting spot of the porous structurematerial. As described above, in cases where the porous structurematerial is formed with the technique for the hot pressing describedabove, the barrier is formed automatically with the hot pressing.Alternatively, the barrier may be formed with heat fusion after theporous structure material has been formed.

As another alternative, circular pieces of the nitrocellulose membraneor the polysulfone membrane, which have a diameter of 300 μm and havebeen impregnated with reagent, may be attached to a differentnitrocellulose membrane or a different polysulfone membrane, such thatthe circular pieces of the nitrocellulose membrane or the polysulfonemembrane may be located at a predetermined spacing from one another andconstitute independent reagent areas. In this manner, a structurethrough which the water-soluble reagent does not permeate is capable ofbeing formed around the reagent areas.

As for the blood constituent separating membrane, such as the bloodconstituent separating membrane 16 illustrated in FIG. 2, in cases wherethe reagent layer is pushed against the blood constituent separatingmembrane, a protective membrane for preventing the blood constituentseparating membrane from being damaged should preferably be overlaid onthe surface of the blood constituent separating membrane, which surfacecomes into contact with the reagent layer. In order for the effect ofthe protective membrane to be confirmed, the experiments described belowwere performed. Specifically, a nylon mesh, which had a thicknessfalling within the range of 300 μm to 400 μm and through which aplurality of apertures having a diameter falling within the range of 200μm to 400 μm had been perforated at 1 mm pitches, was laminated with ablood constituent separating membrane constituted of a polysulfonemembrane. A circular piece having a diameter of 10 mm was then punchedout from the resulting laminate and fitted in a plastic circularcylinder having an inner diameter of 10 mm and a length of 20 mm.Thereafter, 50 μl (microliter) of whole blood was spotted onto thecircular piece of the laminate from the side of the nylon mesh. Also, aplastic circular cylinder having an outer diameter of 6 mm, in which anitrocellulose membrane having a diameter of 6 mm had been fitted to abottom surface, was inserted into the aforesaid plastic circularcylinder from the side of the polysulfone membrane and brought intocontact with the polysulfone membrane at a pressure falling within therange of 300 Kg/m² to 500 Kg/m². A comparative experiment was conductedin the same manner as that described above, except that the nylon meshwas not laminated with the polysulfone membrane.

As a result, it was found that the polysulfone membrane which had notbeen laminated with the nylon mesh suffered from damage, and thepolysulfone membrane which had been laminated with the nylon mesh didnot suffer from any damage.

A further different example of the reagent layer constituting the bloodtesting unit in accordance with the present invention will be describedhereinbelow.

In this example, a nitrocellulose porous membrane having a pore diameterof 0.45 μm (supplied by Millipore Corporation) was attached to slideglass for microscopic observation, which had a size 1 inch×3 inches.Also, an MES buffer solution, which contained glucose oxidase,peroxidase, 1,7-dihydroxy naphthalene, and 4-amino antipyrine and hadbeen adjusted to a pH value falling within the range of 5.5 to 6.5, wasspotted onto the nitrocellulose porous membrane by use of a microspotter. More specifically, 24 spots (i.e., four spots arrayed in thevertical direction x six spots arrayed in the horizontal direction) ofthe MES buffer solution, each of which had a diameter of approximately200 μm, were formed at intervals of 600 μm on the nitrocellulose porousmembrane. The thus formed spots were then dried. In this manner, glucosedetecting spots, which were of the pigment types and had the absorptioncharacteristics such that the maximum absorption wavelength was in thevicinity of 505 nm, were formed.

A halogen lamp was utilized as a light source, and light having apredetermined intensity was produced by the halogen lamp. The lighthaving been produced by the halogen lamp was passed through an opticalfilter for transmitting light having a wavelength of 505 nm, andmonochromatic light for use as the measuring light was thus obtained.Also, a sample support base was secured at a position spaced by adistance falling within the range of 10 cm to 30 cm from the lightsource, and it was set such that the distance between the nitrocelluloseporous membrane placed on the sample support base and the light sourcewas kept at a predetermined value. Further, an optical system forguiding the reflected light, which was reflected from the glucosedetecting spots of the nitrocellulose porous membrane when measuringlight was irradiated to the glucose detecting spots, through a lenssystem having a 10-power magnification to a CCD detector was located.

Within a photometric system blocked from external light, the intensityof light, which was received by each of devices constituting the CCDdetector when the measuring light was blocked, was measured. The thusmeasured light intensity was stored as the light intensity at the timeof 0% reflectivity. Thereafter, a white plate was located at the sameposition as the position of the nitrocellulose porous membrane, and theintensity of light, which was received by each of devices constitutingthe CCD detector, was measured. The thus measured light intensity wasstored as the light intensity at the time of 100% reflectivity.

The nitrocellulose porous membrane was secured at a predeterminedposition, and human blood serum was spotted such that the 24 detectingspots of the nitrocellulose porous membrane were reliably wetted withthe human blood serum. Also, while the light having a wavelength of 505nm was being irradiated to the nitrocellulose porous membrane, theintensity of the reflected light coming from the nitrocellulose porousmembrane was measured one time per 10 seconds. The thus measuredintensity of the reflected light was converted into an optical densityof each of the detecting spots having formed the colors. The value ofthe optical density of each of the detecting spots reached apredetermined value within approximately one minute after the bloodserum was spotted. The value of the optical density obtained at thistime was taken as an end point. In the same manner as that describedabove, a plurality of blood serums, in which the glucose concentrationswere adjusted at different values, were spotted, and a calibration curveof the optical density with respect to the glucose concentration wasthereby formed. In accordance with the thus formed calibration curve, aglucose concentration of an arbitrary human blood serum was capable ofbeing calculated.

A still further different example of the reagent layer constituting theblood testing unit in accordance with the present invention will bedescribed hereinbelow. In this example, 36 apertures (i.e., sixapertures arrayed in the vertical direction×six apertures arrayed in thehorizontal direction), each of which had a diameter of falling withinthe range of 200 μm to 500 μm, were formed at intervals two times aslarge as the aperture diameter through a polyethylene plate, which wascolored in black, or a stainless steel plate having a black surface. Anitrocellulose membrane was then embedded in the apertures. Also, an MESbuffer solution, which contained glucose oxidase, peroxidase,1,7-dihydroxy naphthalene, and 4-amino antipyrine and had been adjustedto a pH value falling within the range of 5.5 to 6.5, was spotted ontothe nitrocellulose membrane by use of a micro spotter. The spottedsolution was then dried.

As for the thus formed reagent layer, in the same manner as thatdescribed above, it had been confirmed that the glucose concentration ofhuman blood serum is capable of being measured.

Elements constituting the blood testing apparatus in accordance with thepresent invention will hereinbelow be described in more detail.

As the light source for producing the measuring light, besides theaforesaid light emitting diode for producing the monochromatic light orthe white light, a white light source, such as a halogen lamp or a xenonlamp, may be employed. Also, as the means for converting the measuringlight into monochromatic light, an optical filter, which transmits thelight having wavelengths falling within a range of approximately acenter wavelength ±3 nm, is capable of being utilized appropriately.Alternatively, a filter having comparatively bad monochromaticcharacteristics and transmitting the light having wavelengths fallingwithin a range of approximately a center wavelength ±30 nm, whichwavelengths fall within the range of the absorption wavelengths of thereagents having formed the colors, may be utilized. As anotheralternative, a light emitting diode, a semiconductor laser, or the like,which has good monochromatic characteristics and transmits only thelight having a wavelength falling within the range of the absorptionwavelengths of the reagents having formed the colors, may be utilizedalone without being combined with a filter.

As the means for detecting the light having been reflected from thereagent layer, besides the aforesaid CCD detector, means capable ofperforming simultaneous multiple-point detection, such as a photodiodearray or an optical multi-analyzer, may be utilized. Alternatively, aplurality of devices, each of which is capable of performingsingle-point detection, such as photomultipliers, may be arrayed andutilized.

In order to obtain the photo detection signal S in cases where thereflectivity of the reagent layer with respect to the measuring light is0%, besides the dummy unit 10K shown in FIG. 19 and the chopper 251shown in FIG. 24, one of various other means capable of blocking themeasuring light, which travels toward the reagent layer, or the light,which has been reflected from the reagent layer and travels toward thephotodetector, may be utilized. As such means, besides the means forsimply blocking the light, the means, which changes the intensity of thelight or the direction of the optical path of the light by theutilization of light interference, refraction, or diffraction, may beemployed. Alternatively, instead of the light being blocked optically,electric power supplied to the light source for producing the measuringlight may be blocked, and the photo detection signal S obtained from thephotodetector at this time may be taken as the photo detection signalobtained in cases where the reflectivity is 0%.

In order to obtain the photo detection signal S in cases where thereflectivity of the reagent layer with respect to the measuring light is100%, besides the white plate 23W of the dummy unit 10W shown in FIG.19, operation may be performed, wherein the measuring light isirradiated to a gray plate, a blue plate, a green plate, a yellow plate,and a red plate, whose optical densities are known. From the photodetection signal S obtained at this time, the photo detection signal Sat the time of 100% reflectivity may be calculated.

Also, a black plate, which is of the same type as the black plate 23K ofthe dummy unit 10K described above, and a white plate, which is of thesame type as the white plate 23W of the dummy unit 10W, may be formed atcertain areas of the reagent layer 24. The measuring light may beirradiated to the black plate and the white plate. In this manner, thephoto detection signal S at the time of the 0% reflectivity and thephoto detection signal S at the time of the 100% reflectivity may beobtained.

Further, the technique, with which the blood testing apparatus makes ajudgment as to the start point of the color forming reaction of thereagent layer, is not limited to the technique for measuring theintensity of the light reflected from the reagent layer. Specifically, acertain region or the entire region of the blood testing unit may bebrought into direct or indirect contact with the blood testingapparatus, and the judgment as to the start point of the color formingreaction of the reagent layer may thus be made. As another alternative,a signal representing the start of the color forming reaction may be fedinto the blood testing apparatus with a manual operation, which isperformed simultaneously with the loading of the blood testing unit intothe blood testing apparatus.

Although the embodiments of the present invention are described above asfor the blood testing unit, the present invention is applicable to testsof bodily fluids other than the blood, and the similar effects arecapable of being obtained.

1. A blood testing unit, comprising: a closed vessel, which is providedwith an aperture, through which air is capable of being introduced froman exterior to an interior of the closed vessel, and the closed vesselbeing provided with a sealing member for closing the aperture forintroducing air, and a blood testing reagent located in the closedvessel, wherein the closed vessel comprises an outer vessel body, whichhas a bottom wall, and an inner vessel body, which has a bottom wall,and the outer vessel body and the inner vessel body are combined witheach other, such that the outer vessel body and the inner vessel bodyare capable of sliding with respect to each other, while a space definedby the outer vessel body and the inner vessel body is being kept in anapproximately hermetically sealed state, the outer vessel body and theinner vessel body thus defining an enclosed space at the interior in amanner such that a pressure in the enclosed space is capable of beingreduced.
 2. The blood testing unit as defined in claim 1, wherein thesealing member is a sheet-shaped member, which is adhered to the closedvessel.
 3. The blood testing unit as defined in claim 1, wherein theouter vessel body and the inner vessel body are provided with lockingmeans for keeping the states of the outer vessel body and the innervessel body when at least either one of the outer vessel body and theinner vessel body has moved with respect to the other in a directionwhich increases a volume of the enclosed space defined at the interior,by the outer vessel body and the inner vessel body, and the pressure inthe enclosed space has thus been set at a negative pressure.
 4. Theblood testing unit as defined in claim 1, wherein an O-ring is fittedonto an outer peripheral wall of the inner vessel body, the O-ring beingcapable of keeping the space, which is defined by the outer vessel bodyand the inner vessel body, in an approximately hermetically sealedstate, and the outer vessel body and the inner vessel body are capableof sliding with respect to each other, while the O-ring fitted onto theouter peripheral wall of the inner vessel body is in contact with aninner peripheral wall of the outer vessel body.
 5. The blood testingunit as defined in claim 1, wherein an outer peripheral wall of theinner vessel body is provided with an engagement section, which projectsoutwardly from an outer peripheral wall of the inner vessel body, aninner peripheral wall of the outer vessel body is provided with anengagement section, which projects inwardly from the inner peripheralwall of the outer vessel body, and the engagement section of the innervessel body and the engagement section of the outer vessel body arecapable of engaging with each other in order to prevent the inner vesselbody and the outer vessel body from separating from each other.
 6. Theblood testing unit as defined in claim 1, wherein the blood testingreagent is capable of forming a color as a result of a reaction with ablood plasma andlor a blood serum.
 7. The blood testing unit as definedin claim 1, wherein the aperture is formed on the inner vessel body. 8.The blood testing unit as defined in claim 1, wherein the blood testingreagent is provided on a reagent layer, the reagent layer disposed in aposition within the closed vessel.
 9. A blood testing unit, comprising:a closed vessel, which is provided with an aperture, through which airis capable of being introduced from an exterior to an interior of theclosed vessel, and the closed vessel being provided with a sealingmember for closing the aperture for introducing air; and a blood testingreagent located in the closed vessel, wherein the closed vesselcomprises an outer vessel body, which has a bottom wall, and an innervessel body, which has a bottom wall, wherein the outer vessel body andthe inner vessel body are combined with each other, such that the outervessel body and the inner vessel body are capable of sliding withrespect to each other, while a space defined by the outer vessel bodyand the inner vessel body is being kept in an approximately hermeticallysealed state, the outer vessel body and the inner vessel body thusdefining an enclosed space at the interior in a manner such that apressure in the enclosed space is capable of being reduced, wherein theblood testing reagent is capable of forming a color as a result of areaction with a blood plasma and/or a blood serum, and wherein theaperture is formed on the inner vessel body.